BR122017005090A2 - system, method, and apparatus for monitoring, regulating, or controlling a fluid flow - Google Patents

Abstract

A system, method, and apparatus for monitoring, regulating, or controlling a fluid flow The present invention relates to an apparatus, system and method for regulating fluid flow. The apparatus includes a flow rate sensor and a valve. The flow rate sensor uses images to estimate flow through the drip chamber and then controls the valve based on the estimated flow rate. The valve comprises a rigid housing disposed around the pipe in which fluid flow is being controlled. Increasing pressure within the housing controls the size of the lumen within the tube by deforming the tube, thereby controlling the flow through the tube.

Description

Invention Patent Descriptive Report for SYSTEM, METHOD, AND APPARATUS TO MONITOR, REGULAR, OR CONTROL A FLUID FLOW.

[001] Divided from BR112015023438-0, deposited on March 14, 2014.

BACKGROUND

RELEVANT FIELD [002] The present invention is concerned with monitoring, regulating, or controlling a fluid flow. More specifically, the present description relates to a system, method, and apparatus for monitoring, regulating, or controlling a fluid flow, for example, for use in medical applications such as intravenous infusion therapy, dialysis, transfusion therapy, peritoneal infusion therapy, bolus application, enteral nutrition therapy, parenteral nutrition therapy, hemoperfusion therapy, fluid resuscitation therapy, or insulin application, among others.

DESCRIPTION OF THE RELATED TECHNIQUE [003] In many medical settings, a common mode of medical treatment involves applying fluids to a patient, such as a human, animal, or domestic animal. The need may arise to quickly infuse a fluid into the patient, precisely to infuse the fluid into the patient, and / or to slowly infuse the fluid into the patient. Saline and lactated ringers are examples of commonly used fluids. Such fluids can be used to maintain or raise blood pressure and promote adequate perfusion. In the shock - trauma or septic shock environment, fluid resuscitation is often a first - line therapy to maintain or improve blood pressure.

[004] The application of fluid to the patient can be facilitated by the use of a line (or tube) fed by gravity inserted in the

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2/190 patient. Typically, a fluid reservoir (for example, an IV pouch) is hung from a rod and is connected to the fluid tube. The fluid tube is sometimes attached to a drip chamber to trap air and estimate fluid flow. Below the fluid tube can be a manually actuated valve used to adjust fluid flow. For example, by counting the number of drops formed within the drip chamber within a certain amount of time, a caregiver can calculate the rate of fluid flowing through the drip chamber and adjust the valve (if necessary) to achieve a rate of desired flow.

[005] Certain treatments require that the fluid delivery system adhere strictly to the flow rate set by the caregiver. Typically, such applications use an infusion pump, but such pumps may not be used in all situations or environments.

SUMMARY [006] Briefly and in general terms, the present description refers to a system, method, and apparatus for monitoring, regulating, or controlling a fluid flow, for example, for use in medical applications such as infusion therapy intravenous, dialysis, transfusion therapy, peritoneal infusion therapy, bolus application, enteral nutrition therapy, parenteral nutrition therapy, hemoperfusion therapy, fluid resuscitation therapy, or insulin application, among others. More specifically, the present description relates to a fluid flow meter to monitor the fluid flow associated with a patient, a valve to regulate the fluid flow associated with the patient, and / or a coupled fluid flow meter to a valve (for example, arranged in a closed-loop, open-loop, or return configuration) to monitor, regulate and / or control the use of fluid associated with the patient.

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3/190 [007] In some embodiments of this description, a flow meter includes one or more optical sensors to monitor the flow of fluid within a tube, for example, using an image sensor to monitor the droplets inside a chamber drip trap attached to the tube. The flow meter can be an independent device, can be used in conjunction with either a pump or a valve, or both, and / or can be used to provide a return for any electronic device. The flow meter can be remotely controlled, for example, by a monitoring client, a remote communicator, a smartphone, a computer, etc. The flow meter can measure the average flow rate, an instantaneous flow rate, a drop volume, a drop growth rate, or other parameters related to fluid flow.

[008] The flow meter can use the flow rate or the fluid flow parameter to: (1) display the flow rate or parameter on a screen, (2) provide feedback, such as the flow rate or the parameter relating to fluid flow (wireless or through wires), for an infusion pump such as a peristaltic pump, (3) providing feedback to a monitoring client or remote monitoring client such as a smartphone, (4) issuing alarms when the flow rate or fluid flow parameter is out of a predetermined range, (5) emit an alarm when the flow rate or fluid flow parameter is above a predetermined limit, (6) issue an alarm when a free flow is detected, (7) report alarms to a pump, a monitoring client, or a remote monitoring client, (8) instruct a valve to stop the flow of fluid when a free flow is detected , an alarm is issued and / or the ta flow rate or the fluid flow parameter is above a limit or outside a predetermined range, and / or (9) transmits the flow rate or parameter relative to the

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4/190 fluid flow.

[009] In some embodiments described here, a valve regulates the fluid flow associated with a patient. The valves described here can be manually actuated or can be actuated with an actuator (or both). The valve can be used with or without a pump, with or without a flow meter, and / or it can be an independent device. The valve can be remotely controlled, for example, by a monitoring client, a remote communicator, a smartphone, a computer, etc. The valve can compress a tube over a portion that is substantially larger than the diameter of the tube, for example, 2 times larger, 5 times larger, 10 times larger, etc.

[0010] The valve can be made of two or more pieces that compress the tube or it can be made of a single piece that compresses the tube as the piece is moved or deformed. The two or more pieces and / or the single piece can be made using injection molding, ultrasonic welding, using multiple pieces that are glued or molded together, or the like. Each of the two or more pieces can be made by one or more subparts that are fixable to each other either permanently or temporarily. The single part can be made by one or more subparts that are coupled together or permanently or temporarily, for example, using ultrasonic welding, gluing, coupling, or another technique. The pieces can be made of plastic, metal, an alloy, a polymer, or other material.

[0011] In some embodiments of the present description, a flow meter is coupled to a valve to regulate the flow of fluid, for example, the flow of fluid to a patient. The flow meter attached to the valve can be used with a pump, such as a peristaltic infusion pump, or it can be used without a pump (for example, the flow meter can replace the

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5/190 a peristaltic pump). The flow meter and valve combination can be remotely controlled, for example, by a monitoring client, a remote communicator, a smartphone, a computer, etc. or it can be remotely monitored. A monitoring client can control the flow meter or valve, can be a relay between the flow meter and valve, can monitor the operation of the flow meter or valve, can communicate information regarding the flow meter or valve to a server, and / or may not be used in the system.

[0012] The flow meter can monitor the fluid flow and make adjustments, directly or indirectly, to a valve or a pump (for example, an infusion pump). The flow meter can alarm when it detects free flow conditions, determines whether the flow rate is greater than a predetermined limit or is outside a predetermined range, and / or detects any abnormal behavior. The flow meter, in response to an alarm or condition, can cause the flow meter to stop the flow of fluid, instruct a valve to stop the flow of fluid, instruct a safety valve to stop the flow of fluid, notify a monitoring client or remote communicator, transmit the detected condition, or execute a predefined routine or algorithm.

[0013] In certain embodiments of the present description, an apparatus for regulating fluid flow includes an elongated, curved support member and an opposite support member. The elongated, curved support member is elastically deformable and has a first and second ends. The opposite support member is configured to position a tube against the elongated support member, curved between the first and second ends so that the deformation of the elongated support member, curved by the movement of the first and second ends towards each other reduces an internal volume

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6/190 of the tube. The opposite support member can be another elongated, curved support member.

[0014] The apparatus may include an actuator coupled to the elongated support member, curved to deform the elongated support member, curved by the movement of the first and second ends towards each other by the actuation of the actuator. In some such embodiments, the actuator may be a lead screw, and a button may be attached to the lead screw to actuate the lead screw.

[0015] The actuator, the elongated, curved support member and the opposite support member can be configured to regulate the flow of fluid by actuating the actuator according to a Gompertz curve. The actuator can also be configured, in some modalities, to act the first and second ends towards each other along a predetermined portion of the Gompertz curve. For example, the actuator can only actuate the actuator over a portion of the actuable range of the elongated, curved support member and the opposite support member.

[0016] The actuator, the elongated, curved support member and the opposite support member can be configured to regulate the flow of fluid by actuating the actuator according to a sigmoid curve. The actuator can be further configured to actuate the first and second ends towards each other along a predetermined portion of the sigmoid curve.

[0017] The elongated, curved support member can be semi-rigid and / or can consist essentially of a stretchable material. The elongated, curved support member can be an elongated, arched support member, and / or it can be C-shaped.

[0018] The apparatus may also comprise an elongated connecting member operatively coupled to the first and second ends

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7/190 mities of the elongated, curved support member.

[0019] In certain embodiments of the present description, the apparatus may comprise an actuator coupled to the elongated connecting member and the elongated support member, curved to apply an expanding force outwardly thereby deforming the first and second ends of the members elongated support plates, curved towards each other.

[0020] In certain embodiments of the present description, the elongated, curved support member is arranged approximately parallel to the other elongated, support member curved over a substantial portion. For example, the elongated, curved support member defines a length, and the other elongated, curved support member defines a length and the length of the other elongated, curved support member is arranged approximately parallel with the length of the elongated support member, curved.

[0021] In certain embodiments of the present description, the apparatus includes an actuator operatively coupled to the elongated support member, curved at the first and second ends, and In another elongated support member, curved at the first and second ends. The actuation of the actuator causes the first and second ends of the elongated, curved support member to approach each other and also causes the first and second ends of the other elongated, curved support member to approach each other by way of this causes a reduction in distance between the elongated, curved support member and the other elongated, curved support member to thereby compress the tube.

[0022] In certain embodiments of the present description, the elongated, curved support member defines a length, and the opposite support member is arranged orthogonally of the length over a portion thereof.

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8/190 [0023] In certain embodiments of the present description, the elongated, curved support member includes a plurality of edges disposed on it to couple the tube.

[0024] In certain embodiments of the present description, the opposite support member includes a plurality of edges arranged thereon configured to couple the tube.

[0025] In certain embodiments of the present description, the elongated, curved support member includes a flange that extends its length configured to secure the tube. The opposite support member may include another flange extending its length configured to secure the tube so that the flange and the other flange are approximately parallel to each other and are approximately parallel to a central geometric axis defined by the tube when the tube is disposed among these.

[0026] In certain embodiments of the present description, an apparatus for regulating the flow of fluid includes a first elongated support member, a second elongated support member, and an actuator. The first elongated support member defines a length, and the second elongated support member also defines its own length so that the length of the second elongated support member is arranged in a spaced relationship with the length of the first elongated support member to cooperate with the first elongated support member for compressing a tube. The actuator is in mechanical coupling with at least one of the first and second elongated support members to actuate the first and second elongated support members towards each other thereby compressing a tube arranged between them to regulate the flow of fluid within of the tube so that the actuation of the actuator acts on the first and second elongated support members to regulate the flow of fluid inside the tube according to an appropriate sigmoid curve

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9/190 maximum.

[0027] The length of the second elongated support member may be approximately approximately parallel to the length of the first elongated support member. The first and second elongated support members can be configured to cooperate with each other to compress the tube over a length of the tube at least substantially greater than the diameter of the tube. The actuator can be configured to actuate the first and second elongated support members to compress the tube to regulate the flow of fluid within the tube along a predetermined portion of the sigmoid curve.

[0028] In certain embodiments of the present description, an apparatus for regulating fluid flow includes an elongated first and second support members. The first elongated support member defines a length and the second elongated support member defines a length. The length of the second elongated support member is arranged in a spaced relationship with the length of the first elongated support member to cooperate with the first elongated support member to compress a tube. The actuator is in mechanical coupling with at least one of the first and second elongated support members to actuate the first and second elongated support members towards each other thereby compressing a tube arranged between them to regulate the flow of fluid within of the tube so that the actuation of the actuator acts on the first and second elongated support members to regulate the flow of fluid inside the tube according to an approximate Gompertz curve.

[0029] The length of the second elongated support member may be approximately approximately parallel to the length of the first elongated support member. The first and second members

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10/190 elongated support can be configured to cooperate with each other to compress the tube over a length at least substantially greater than the diameter of the tube.

[0030] The actuator can be configured to actuate the first and second elongated support members to compress the tube to regulate the flow of fluid within the tube according to a predetermined portion of the Gompertz curve.

[0031] In certain embodiments of the present description, an apparatus for regulating fluid flow includes an elongated first and second support members. The first elongated support member defines a length, and the second elongated support member defines a length so that the length of the second elongated support member is arranged in a spaced relationship with the length of the first elongated support member to cooperate with the first elongated support member for compressing a tube. The actuator is in mechanical coupling with at least one of the first and second elongated support members to actuate the first and second elongated support members towards each other thereby compressing a tube arranged between them to regulate the fluid flow inside the tube so that the actuation of the actuator acts on the first and second elongated support members to regulate the flow of fluid inside the tube according to an approximate generalized logistic function.

[0032] The length of the second elongated support member may be approximately approximately parallel to the length of the first elongated support member. The first and second elongated support members can be configured to cooperate with each other to compress the tube over a length of the tube at least substantially greater than the diameter of the tube. The actuator can also be configured to act the first and second

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11/190 elongated support members to compress the tube to regulate the flow of fluid within the tube according to a predetermined portion of the generalized logistic function.

[0033] In certain embodiments of the present description, an apparatus for regulating the flow of fluid includes a first and second support members, and an actuator. The first support member forms at least one of an arc, a plurality of arcs, a curve, a plurality of curves, an arcuate shape, a plurality of arcuate shapes, an S shape, a C shape, a convex shape, a plurality of convex shapes, a concave shape, and a plurality of concave shapes. The second support member is arranged in spaced relation with the first support member to cooperate with the first support member to compress a tube along a length of the tube at least substantially greater than the diameter of the tube. The actuator is in mechanical coupling with at least one of the first and second support members to actuate the first and second support members towards each other, thereby compressing a tube arranged between them to regulate the flow of fluid within the tube so that the actuation of the actuator acts on the first and second support members to regulate the flow of fluid inside the tube according to an approximate non-linear function.

[0034] The approximate non-linear function can be an approximate generalized logistic function, an approximate sigmoid curve, and / or an approximate Gompertz curve. The actuator can be configured to thereby regulate the flow of fluid within the tube according to a predetermined portion of the approximate nonlinear function.

[0035] In certain embodiments of the present description, the first support member forms an arc, has a shape that consists of

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12/190 essentially in an arc, forms a plurality of arcs, has a shape that essentially consists of a plurality of arcs, forms a curve, has a shape that essentially consists of a curve, forms a plurality of curves, has a shape that consists essentially of a plurality of curves, forms an arcuate shape, has a shape which consists essentially of an arcuate shape, forms a plurality of arcuate shapes, has a shape which essentially consists of a plurality of arcuate shapes, forms an S shape, has a shape that essentially consists of an S shape, forms a shape in C, has a shape that consists essentially of a C shape, forms a convex shape, has a shape that consists essentially of a convex shape, forms a plurality of convex shapes, has a shape that essentially consists of a plurality of convex shapes, forms a concave shape, has a shape that essentially consists of a concave shape, fo forms a plurality of concave shapes, and / or has a shape that essentially consists of a plurality of concave shapes.

[0036] A length of the second support member can be arranged approximately parallel to a length of the first support member. The first and second support members can be configured to cooperate with each other to compress the tube over a length of the tube at least substantially greater than the diameter of the tube.

[0037] In certain embodiments of the present description, an apparatus for regulating fluid flow includes an elongated, curved support member and an opposite support member. The elongated, curved support member is elastically deformable and has a first and second ends. The opposite support member is configured to define a conduit with the elongated, curved support member

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13/190 that the conduit is defined between the elongated, curved support member and the opposite member. The deformation of the elongated support member, curved by the movement of the first and second ends towards each other reduces an internal volume of the conduit. In some embodiments, the conduit may be configured to receive a tube. In still further embodiments, the conduit is fluidly sealed, and the apparatus further comprises a first and a second port in fluid communication with the conduit so that each port is adapted to be coupled to a tube.

[0038] In certain embodiments of the present description, a system for regulating the flow of fluid includes a flexible tube and a reverse Bourdon tube valve. The flexible fluid tube has a fluid path and is configured to pass a fluid through it. The reverse Bourdon tube valve is coupled to the flexible fluid tube to regulate the fluid flowing through the fluid path of the flexible fluid tube. An actuator may be coupled to the reverse Bourdon tube valve to actuate the reverse Bourdon tube valve to regulate the fluid flowing through the fluid path of the flexible fluid tube. A reverse Bourdon tube valve works in the opposite way to a Bourdon tube in which a fluid path deformation causes changes in the fluid flow instead of the fluid flow causing the fluid path deformation.

[0039] In certain embodiments of the present description, a system for regulating fluid flow includes a fluid tube, a valve, and an actuator. The fluid tube defines a fluid path configured to pass the fluid through it. The valve is operatively coupled to the fluid tube and includes a flexible first and second members. The second flexible member is operatively coupled to the first flexible member. The fluid tube is arranged between the first and second flexible members, and the first and second fle members

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14/190 levels are configured to flex to thereby regulate the flow of fluid that passes through the fluid tube. The actuator is coupled to at least the first end of the first flexible member and a second end of the first flexible member. The actuator can be a lead screw and there may be an electrically powered motor attached to the lead screw to turn the lead screw.

[0040] In certain embodiments of the present description, the system may include a button attached to the lead screw so that the button is configured to turn the lead screw. The button can be coupled by a motor-driven actuator.

[0041] In certain embodiments of the present description, the actuator is coupled to a first end of the first flexible member and a second end of the first flexible member, and the actuator is configured to at least one of the first and second ends to flex one in the direction the other and flex the first and second ends away from each other. The actuator can flex the first and second ends away from each other and / or the actuator flexes the first and second flexible members so that the first and second ends approach each other. The first and second flexible members can generally be rectangular. The first member and / or the second member can be tensioned to at least substantially the fluid flow when the actuator ceases to apply force.

[0042] The system may include a flow meter coupled to a drip chamber that is coupled to the fluid tube so that the flow meter estimates the flow of fluid through the drip chamber and therefore also estimates the flow of fluid through the fluid tube. The flow meter can be an image sensor based flow meter.

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15/190 [0043] The flow meter can be operatively coupled to a motor to actuate the valve, and the system can include a control component to control the motor to actuate the valve to achieve the desired flow rate as estimated by the meter flow.

[0044] In certain embodiments of the present description, an apparatus for regulating fluid flow includes a first and a second C-shaped member. The first C-shaped member defines internal and external surfaces, and the second C-shaped member. defines internal and external surfaces. At least one of the outer surface of the first C-shaped member and the inner surface of the second C-shaped member is configured to receive a tube. The internal surface of the second C-shaped member is arranged in a spaced relationship to the external surface of the first C-shaped member. A substantial area of the internal surface of the second C-shaped member can, in some specific embodiments, cover the outer surface of the first C-shaped member.

[0045] In certain embodiments of the present description, the second C-shaped member is flexible and the first C-shaped member is semi-rigid, rigid and / or is an elastomer.

[0046] A flexible member can be formed from a material selected from the group consisting of a plastic, a polymer, a monomer, a polypropylene, a thermoplastic polymer, a ceramic, a polyvinyl chloride, and a polyethylene.

[0047] In certain embodiments of the present description, an apparatus for regulating fluid flow includes a first and a second flexible plate. The second flexible plate is operatively coupled to the first flexible plate. The first and second flexible sheets are configured to receive a fluid tube between them, and the first and second flexible sheets are also configured to flex to thereby regulate the flow of fluid that passes through the tube.

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16/190 of fluid.

[0048] The apparatus may include an actuator coupled to a first end of the first flexible plate and the second end of the first flexible plate. The actuator can be configured for at least one to flex the first and second ends towards each other and to flex the first and second ends away from each other.

[0049] The apparatus may include a lead screw attached to a first end of the first flexible plate and a second end of the first flexible plate, and a button attached to the lead screw so that the rotation of the button rotates the lead screw. The button can be configured for coupling with a motor driven actuator by means of which the motor driven actuator acts on the button.

[0050] In certain embodiments of the present description, an apparatus for regulating fluid flow includes a first and a second curve-shaped member. The first curved member defines inner and outer surfaces, and the second curved member also defines inner and outer surfaces. The inner surface of the second curved member is arranged in a spaced relationship to the outer surface of the first curved member.

[0051] At least one of the first and second curved members can be configured to position a fluid tube between them The first curved member can be at least one semi-rigid and rigid. The second curved member can be flexible. The second curved member can comprise an elastomer. The first and second curved members can be flexible.

[0052] The device can comprise a connecting member

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17/190 operatively coupled to at least one of a first end of the first curved member and a first end of the second curved member so that the connecting member is also operatively coupled to at least one of the second end of the first curved member and a second end of the second curved member. The connecting member may be flexible, may be rigid, and / or may be semi-rigid.

[0053] The device can include an actuator positioned between the connecting member and the second curved member to apply a force between them when actuated. The actuator can be a lead screw.

[0054] In certain embodiments of the present description, an apparatus for regulating the flow of fluid includes a first and second curved members. The first curved member defines internal and external surfaces. The first curved member has first and second receiving members at opposite ends of the first curved member. The second curved member defines internal and external surfaces. The second curved member has a first and second fasteners at opposite ends of the second curved member. At least one of the first and second fasteners can be a hook. The first receiving member of the first curved member is configured to engage the first fastener of the second curved member, and the second receiving member of the first curved member is configured to engage the second fastener of the second member shaped like a curve.

[0055] At least one of the receiving members can be a cylindrically formed member, such as a drum nut, configured to couple with a hook.

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18/190 [0056] At least one of the receiving members can be operatively coupled to an actuator. One or more of the receiving members can be operatively coupled to an electric motor.

[0057] In certain embodiments of the present description, the apparatus also includes an electric motor coupled to the first receiving member so that: (1) the electric motor rotates a rotor coupled to an axis that has threads on its external surface; (2) the second receiving member defines a threaded hole configured to receive the shaft; and (3) the threaded hole and the shaft cooperate together for at least one to increase or decrease the distance between the first and second receiving members when the electric motor rotates the rotor to thereby rotate the shaft.

[0058] In certain embodiments of the present description, an apparatus for regulating fluid flow includes an elongated, curved first and second support members. The first elongated, curved support member is elastically deformable and has a first and second ends. The second elongated, curved support member is elastically deformable and has a first and second ends. The second elongated, curved support member is configured to position a tube against the first elongated support member, curved so that the deformation of the first and second elongated support members, curved by the movement of the first and second ends of the first support member elongated, curved towards each other reduces an internal volume of the tube.

[0059] The first connector is coupled to the first end of the first elongated, curved support member and is also coupled to the first end of the second elongated, curved support member. The second connector is attached to the second end of the first elongated, curved support member and is also attached to the second end of the second support member

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19/190 elongated, curved. The second connector defines a hole. The connecting member has one end attached to the first connector and the other end configured for insertion into the hole in the second connector. The connecting member defines a threaded rod at least along its portion. The button has a ratchet configured to operate over the connector member when moved from the other end of the connecting member towards the end of the connecting member. The button is also configured to couple the threaded rod of the connecting member. The button may include a plurality of fingers configured to engage the threaded rod of the connecting member. The button defines an outer periphery and includes a hole defined in the center of the outer periphery of the button. The hole is configured to receive the threaded rod. The plurality of fingers each arches to couple the threaded rod at a respective end of each of the plurality of fingers.

[0060] The first curved elongated support member defines a first hole adjacent to the first end of the first curved elongated support member. The hole is configured to hold a fluid tube.

[0061] The first elongated, curved support member can define a first notch adjacent to the first end of the first elongated, curved support member so that the notch is configured to receive a fluid tube. The notch may include a neck configured to receive the fluid tube and a circular region configured to retain the fluid tube.

[0062] In certain embodiments of the present description, an apparatus for regulating fluid flow includes a base, a plurality of fingers, and a ring. The base defines a hole configured to receive a fluid tube. The plurality of fingers each has an end attached to the base. The ring is configured to slide from the base and

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20/190 along the plurality of fingers. The movement of the ring away from the base and towards the fingers compresses the fingers against the tube. The ring is configured to friction lock against the plurality of fingers. Each finger includes an elongated end attached to the base and a curved end attached to an opposite end relative to the base.

[0063] In certain embodiments of the present description, an apparatus for regulating fluid flow includes a conically formed member, a complementary member, and an actuator. The conically formed member has a surface for wrapping a tube around it. The complementary member is configured to couple the conically formed member to compress the tube. The actuator is configured to compress the conically formed member against the complementary member to thereby compress the tube.

[0064] In certain embodiments of the present description, an intravenous administration set includes: a flexible tube to direct the flow of fluid within it; a first port at one end of the flexible tube; a second port on a second end of the flexible tube; an elongated support member, curved elastically deformable and having first and second ends; and an opposite support member configured to position the flexible tube against the elongated support member, curved between the first and second ends so that the deformation of the elongated support member, curved by the movement of the first and second ends towards each other reduces an internal volume of the tube.

[0065] The intravenous administration set can also include a drip chamber attached to the flexible tube, another port configured to receive a syringe for injection of fluid into the fluid flow inside the flexible tube, and / or a sliding occlusion coupled to the flexible tube configured to couple the flexible tube to occlude the

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21/190 fluid flow within it.

[0066] The first end of the elongated, curved support member can define a first hole to receive the flexible tube, and the second end of the elongated, curved support member can define a second hole to receive the flexible tube.

[0067] In certain embodiments of the present description, a flow meter includes a coupler, a support member, first and second image sensors, and at least one processor. The coupler is adapted to couple with a drip chamber. The support member is operatively coupled to the coupler. The first image sensor has a first field of view and is operatively coupled to the support member. The first image sensor is positioned to view the drip chamber within the first field of view. The second image sensor has a second field of view and is operatively coupled to the support member. The second image sensor is positioned to view the drip chamber within the second field of view.

[0068] The at least one processor is operatively coupled to the first and second image sensors. The at least one processor receives first image data from the first image sensor and second image data from the second image sensor, and the at least one processor estimates at least one liquid parameters within the drip chamber using the first and second data of image.

[0069] The at least one parameter can be one of a type of liquid formation, the volume of the liquid, and the shape of the liquid. The at least one processor can determine the existence of a free flow condition using at least one of the first and second image data sets.

[0070] The flow meter can also include a background pattern

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22/190 positioned within the field of view of the first image sensor so that the drip chamber is between the first image sensor and the background pattern.

[0071] The at least one flow meter processor can estimate at least one parameters using the first image data set by analyzing a distortion of the background pattern caused by the liquid within the first field of view as seen by the first image sensor . The background pattern can be any network of lines that have at least an angle to an opening of the drip chamber when viewed from the first image sensor within the first field of view using the first image data set.

[0072] The at least one processor can determine that a free flow condition exists when the liquid causes the network of lines to change angles by the distortion caused by the liquid when in the condition and free flow as seen from the first field of view of the first image sensor.

[0073] The at least one processor can compare at least one of the first and second image data with a background image to estimate the at least one parameter.

[0074] The at least one processor can compare at least one of the first and second image data with the background image by calculating at least one of a difference between the at least one of the first and second image data with the background image, a absolute difference between at least one of the first and second image data with the background image, and / or an absolute square difference between the at least one of the first and second image data with the background image.

[0075] The flow meter may include memory readable by processor, non-transient in operational communication with the hair

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23/190 minus one processor so the memory stores an operating set of executable instructions per computer configured to be executed by at least one processor. The operating set of instructions executable by computer, when executed by at least one processor, controls the operation of at least one processor.

[0076] In certain embodiments of the present description, a flow meter includes a coupler, a support member, a bottom pattern, and at least one processor. The coupler is adapted to couple with a drip chamber. The support member is operatively coupled to the coupler. The image sensor has a field of view and is operatively coupled to the support member. The image sensor is positioned to see the drip chamber within the field of view. The background pattern is positioned within the field of view of the image sensor. The background pattern is positioned so that the drip chamber is between the background pattern and the image sensor. The at least one processor is operatively coupled to the image sensor to receive image data from it. The at least one processor is configured to estimate at least one liquid parameter within the drip chamber using the background distortion caused by the liquid as indicated by the image data. The distortion is visible within the field of view of the image sensor by the image sensor. The at least one parameter is at least one of a type of liquid formation, a volume of liquid, and a shape of liquid. The background pattern can be a network of lines that has at least one angle to an opening of the drip chamber when viewed from the image sensor using the image data.

[0077] The at least one processor can determine an existing

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24/190 free flow condition using the background distortion caused by the liquid as indicated by the image data. The at least one processor can determine that a free flow condition exists when the liquid causes the network of lines to change angles by the distortion caused by the liquid when in the free flow condition as seen within the image sensor's field of view.

[0078] The flow meter may also include a readable memory per processor, not transient in operational communication with at least one processor. Processor-readable, non-transient memory can store an operating set of executable instructions per computer configured for execution by at least one processor so that the operating set of executable instructions per computer, when executed by at least one processor, controls the operation of the at least one processor.

[0079] In certain embodiments of the present description, a flow meter includes a coupler, a support member, an image sensor, and at least one processor. The coupler is adapted to couple with a drip chamber. The support member is operatively coupled to the coupler. The image sensor has a field of view and is operatively coupled to the support member so that the image sensor is positioned to see the drip chamber within the field of view. The at least one processor is operatively coupled to the image sensor to receive image data from it so that the at least one processor compares an image of the image data with a reference image to estimate at least one liquid parameter within the imaging chamber. drip. The reference image can be a dynamic reference image. At least one processor can update the reference image by multiplying each pixel of the reference image by a first constant and adding a

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25/190 corresponding pixel of the image multiplied by a second constant.

[0080] The flow meter may include a readable memory per processor, not transient in operational communication with at least one processor. Processor-readable, non-transient memory can include a computer executable instruction set configured for execution by at least one processor so that the computer executable instruction set, when executed by at least one processor, controls the operation of the at least one processor.

[0081] In certain embodiments of the present description, a method for exposing an image sensor implemented by an operative set of instructions executable by computer configured for execution by at least one processor includes: selecting a region of interest; determine whether a pixel is within the region of interest; activate a backlight if the pixel is within the region of interest; and expose the pixel. Activating can activate a subset of lights that includes the backlight. The backlight can form a uniform backlight. The image sensor can include the region of interest and the pixel.

[0082] The operating set of instructions executable by computer may be stored in a processor-readable memory, not transient in operative communication with at least one processor so that at least one processor can execute the method.

[0083] The at least one processor can be coupled to an image sensor so that the at least one processor performs the method using the image sensor. The region of interest can be an image sensor region that forms the image of a drip chamber. The region of interest may correspond to

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26/190 drip chamber.

[0084] The method may also include: receiving a vertical synchronization signal from the image sensor; and receiving a horizontal sync signal from the image sensor. The at least one processor can receive the vertical and horizontal synchronization signals from the image sensor. The at least one processor can activate the backlight according to at least one of the vertical and horizontal synchronization signals. The light can be a light emitting diode.

[0085] In certain embodiments of the present description, a flow meter includes a coupler, a support member, an image sensor, a backlight, and at least one processor. The coupler is adapted to couple with a drip chamber. The support member operatively couples to the coupler. The image sensor has a field of view and is operatively coupled to the support member so that the image sensor is positioned to see the drip chamber within the field of view. The backlight has at least one light. The backlight is coupled to the support member so that the backlight is adapted to illuminate the image sensor to expose the image sensor. The image sensor's field of view at least partially forms the image of at least a portion of the drip chamber. The at least one processor is operatively coupled to the image sensor to receive its image data.

[0086] The at least one processor is configured to: select a region of interest for the image sensor; determine if a pixel from the image sensor is within the region of interest; activate the backlight if the image sensor pixel is within the region of interest; and expose the image sensor pixel.

[0087] The flow meter may also include a readable memory per processor, non-transient readable by at least one process

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27/190 pain. The processor-readable, non-transient memory includes an operating set of executable instructions per processor stored in it configured to make at least one processor, when executed: select the region of interest of the image sensor; determines whether the pixel of the image sensor is within the region of interest; activates the backlight if the image sensor pixel is within the region of interest; and exposes the pixel of the image sensor. The at least one processor can be further configured to: receive a vertical sync signal from the image sensor, and receive a horizontal sync signal from the image sensor. The at least one processor can activate the backlight according to at least one of the vertical and horizontal synchronization signals.

[0088] The at least one processor can select the region of interest and determine whether the pixel of the image sensor is within the region of interest according to the image data. The region of interest is an image sensor region that forms an image of the drip chamber. The region of interest may correspond to the drip chamber.

[0089] The at least one processor can activate a subset of lights that includes the backlight. The backlight can form a uniform backlight.

[0090] In certain embodiments of the present description, a method includes: capturing an image that includes an image from a drip chamber using an image sensor that has a field of view that includes the drip chamber; subtract the image from a background image to thereby generate a difference image; convert each pixel of the difference image to a true value if an absolute value of a respective pixel is beyond a predetermined limit or to a false value if the absolute value of the

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28/190 respective pixel is smaller than the predetermined limit; sum each line of the converted difference image to generate a plurality of sum values, where each sum value of the plurality of sum values corresponds to a respective line of the converted difference image; and examine the plurality of summation values. The method can be implemented by an operating set of executable instructions per processor stored in a readable memory per processor, not transient in operative communication with at least one processor so that at least one processor executes the method.

[0091] The act of examining the plurality of summation values may include determining whether a free flow condition exists within the drip chamber.

[0092] The act of determining whether the free flow condition exists may include determining whether the plurality of summation values includes a plurality of contiguous summation values above another predetermined limit.

[0093] The act of examining the plurality of summation values may include determining whether a drop has been formed within the drip chamber.

[0094] The act of determining whether the drop was formed within the drip chamber may include determining whether the plurality of summation values includes a plurality of contiguous summation values within a predetermined range greater than a minimum value and less than a maximum value.

[0095] The method can optionally include standardizing the plurality of sum values before the act of examining. The act of standardizing can be in accordance with at least one of a spline function, a cubic spline function, a B spline function, a Bezier spline function, a polynomial interpolation, a moving average, a

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29/190 data uniformity function, and a cubic spline function. [0096] The at least one processor can optionally be coupled to the image sensor, and the at least one processor can execute the method using the image sensor.

[0097] The method can optionally include the act of converting each pixel of the difference image to an absolute value of each pixel after the act of subtracting and before the act of converting.

[0098] The method can optionally include the act of converting each pixel of the difference image to a square value of each pixel after the act of subtracting and before the act of converting.

[0099] In certain embodiments of the present description, a flow meter includes a coupler, a support member, a light, and at least one processor. The coupler is adapted to couple with a drip chamber. The support member is operatively coupled to the coupler. The image sensor has a field of view and is operatively coupled to the support member so that the image sensor is positioned to see the drip chamber within the field of view. The light is coupled to the support member and is adapted to illuminate the image sensor to expose the image sensor so that the field of view of the image sensor at least partially forms the image of at least a portion of the drip chamber.

[00100] The at least one processor is operatively coupled to the image sensor to receive image data from it, and the at least one processor is configured to: capture an image that includes an image from a drip chamber using the image sensor that it has a field of view that includes the drip chamber; subtract the image from a background image to thereby generate a difference image; convert each pixel of the difference image to a true value if an absolute value

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30/190 of a respective pixel is beyond a predetermined limit or to a false value if the absolute value of the respective pixel is less than the predetermined limit; sum each line of the converted difference image to generate a plurality of sum values, where each sum value of the plurality of sum values corresponds to a respective line of the converted difference image; and examine the plurality of summation values.

[00101] The flow meter may include a processor-readable, non-transitory memory readable by at least one processor so that the processor-readable, non-transitory memory includes an executable set of executable instructions per processor stored in this configured to cause o at least one processor, when run: capture the image that includes the image of a drip chamber using the image sensor that has a field of view that includes the drip chamber; subtracts the image from the background image to thereby generate the difference image; converts each pixel of the difference image to the true value if the absolute value of the respective pixel is beyond the predetermined limit or to the false value if the absolute value of the respective pixel is less than the predetermined limit; add each line of the converted difference image to generate the plurality of sum values, where each sum value of the plurality of sum values corresponds to the respective line of the converted difference image; and examine the plurality of sum values.

[00102] The at least one processor may still be configured to determine whether a free flow condition exists within the drip chamber when the processor examines the plurality of summation values.

[00103] The at least one processor may still be configured to determine whether the plurality of sum values includes a

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31/190 plurality of contiguous sum values above another predetermined limit when the at least one processor determines whether the free flow condition exists.

[00104] The at least one processor may be further configured to determine whether a drop has been formed within the drip chamber when the at least one processor examines the plurality of summation values.

[00105] The at least one processor may be further configured to determine that a drop has been formed if the plurality of summation values includes a plurality of contiguous summation values within a predetermined range greater than a minimum value and less than one maximum value and a location of the contiguous sum values correspond to a predetermined range of locations in which a drop can form.

[00106] The at least one processor can still be configured to standardize the plurality of summation values before when the at least one processor examines the plurality of summation values.

[00107] The at least one processor can standardize according to at least one of a spline function, a cubic spline function, a B spline function, a Bezier spline function, a polynomial interpolation, a moving average, a data uniformity function , and / or a cubic spline function.

[00108] The flow meter may also include a readable memory per processor, non-transitory that has an operating set of executable instructions per processor stored therein. The processor-readable, non-transitory memory is in operative communication with at least one processor so that the operating set of executable instructions per processor controls the operation of at least one processor.

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32/190 [00109] The at least one processor can still be configured to convert each pixel of the difference image to an absolute value of each pixel after the act of subtracting and before the conversion.

[00110] The at least one processor can still be configured to convert each pixel of the difference image to a square value of each pixel after the act of subtracting and before the conversion.

[00111] In certain embodiments of the present description, a method includes: capturing an image from a drip chamber using an image sensor; identify a plurality of pixels of interest within the image; determining a subset of pixels within the plurality of pixels of interest, wherein each pixel of the plurality of pixels is determined to be within the subset of pixels when there is a path to a baseline that corresponds to the drip chamber; perform a rotation operation on the pixel subset; and estimating a volume of a drop within the drip chamber provided a number of pixels within the rotated subset of pixels.

[00112] The baseline can be a predetermined set of pixels within the image sensor. The plurality of pixels of interest can be identified by comparing the image with a background image.

[00113] The method can optionally include one or more of:

use the background image; update the background image using the image captured by the image sensor; update a network of variances using the image captured by the image sensor; and / or updating a network of integers according to the image captured by the image sensor.

[00114] The background image can be updated according to: p = p (1_a) + a P backgroundj, j backgroundj, j \ ^ background j ^ background inputj, j ' [00115] The variance network can be updated according to:

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33/190 σ ² = (P - P) ² temp \ background, í, j input, í, j) ^S background, í, j ^S background, í, j ^(l ^ background) ⁺ A / ackground ^ temp [00116 ] Each integer in the integer network can correspond to a number of one-pixel updates of the background image. In some specific modalities, the comparison of the image with the background image only compares the pixels within the image with pixels within the background image if a respective integer in the network of integers indicates that a respective pixel within the background image has been updated at least a predetermined number of times.

[00117] The method can optionally include one or more of: identifying a drop in the image and a predetermined band near the edge of the drop; and initializing the background image by adjusting each pixel of the background image to the image unless it is within the identified drop or the predetermined band near the edge of the drop.

[00118] The method may also include adjusting a pixel of the background image to a predetermined value if a corresponding pixel of the image is within the identified drop or within the predetermined band near the edge of the drop. The corresponding pixel in the image has a location that corresponds to the pixel in the background image.

[00119] The method may also include determining a baseline that corresponds to an opening in the drip chamber.

[00120] The act of determining a subset of pixels within the plurality of pixels of interest corresponding to a drop may include determining that each of the plurality of pixels of interest is within the subset of pixels if the respective pixel of the plurality of pixels has a contiguous path back to the baseline of the drop formation in an opening of the drip chamber.

[00121] The method can optionally include one or more of: capturing a first image using the image sensor; identify the

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34/190 drop within the first image and a predetermined band near the edge of the drop; initialize a background image by adjusting each pixel for the first image unless it is within the identified drop or the predetermined band near the edge of the drop; adjust the pixels within the drop region or within the predetermined band to a predetermined value; initialize a network of integers; and initialize a network of variances.

[00122] The method may also include one or more of updating the background image, the network of integers, and / or the network of variances using the image.

[00123] In certain embodiments of the present description, a flow meter includes a coupler, a support member, an image sensor, and at least one processor. The coupler is adapted to couple with a drip chamber. The support member is operatively coupled to the coupler. The image sensor has a field of view and is operatively coupled to the support member. The image sensor is positioned to see the drip chamber within the field of view.

[00124] The at least one processor is operatively coupled to the image sensor to receive its image data, and the at least one processor is configured to: capture an image from a drip chamber using the image sensor; identify a plurality of pixels of interest within the image; determining a subset of pixels within the plurality of pixels of interest, wherein each pixel of the plurality of pixels is determined to be within the subset of pixels when there is a path to a baseline that corresponds to the drip chamber; perform a rotation operation on the subset of pixels; and estimate a drop volume within the drip chamber by counting a number of pixels within the subset of

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35/190 pixels rotated.

[00125] The flow meter may also include a readable memory per processor, non-transitory that has a set of executable instructions per processor stored in it. The processor-readable, non-transitory memory is in operative communication with at least one processor so that the operating set of executable instructions per processor controls the operation of at least one processor.

[00126] The flow meter may also include a processor-readable, non-transitory memory readable by at least one processor so that the processor-readable, non-transitory memory includes a set of executable instructions per process stored in this configured to do with that at least one processor, when run: captures an image from a drip chamber using the image sensor; identify a plurality of pixels of interest within the image; determine a subset of pixels within the plurality of pixels of interest, wherein each pixel of the plurality of pixels is determined to be within the subset of pixels when there is a path to a baseline that corresponds to the drip chamber; perform a rotation operation on the subset of pixels; and estimate a drop volume inside the drip chamber by counting a number of pixels within the rotated subset of pixels.

[00127] The baseline can be a predetermined set of pixels within the image sensor. The plurality of pixels of interest can be identified by comparing the image with a background image. The at least one processor can also be configured to initialize the background image and / or update the background image using the image captured by the image sensor.

[00128] The background image can be updated according to:

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36/190

Ρ = P (l - a) + a P background, í, j background, í, j \ background / background input, í, j '

[00129] The at least one processor can still be configured

to update a network of variances using the image captured by the image sensor.

[00130] The network of variances can be updated according to: σ ² = (P _- P) ² temp \ background,?, J input,?, J / ^S background,?, J ^S background,?, J ( ¹ ^ background) ⁺ ^ background ^S temp [00131] The at least one processor can still be configured

to update a network of integers according to the image captured by the image sensor. Each integer in the integer network corresponds to a number of one-pixel updates of the background image.

[00132] Optionally, in some modalities, the comparison

of the image with the background image only compares the pixels within the image with pixels within the background image if a respective integer in the network of integers indicates that a respective pixel within the background image has been updated at least a predetermined number of times.

[00133] The at least one processor may also be configured to: identify a drop in the image and a predetermined band near the edge of the drop; and initializing the background image by adjusting each pixel of the background image to the image unless it is within the identified drop or the predetermined band near the edge of the drop.

[00134] The at least one processor may be further configured to adjust a pixel of the background image to a predetermined value if a corresponding pixel of the image is within the identified drop or within the predetermined band near the edge of the drop.

[00135] In certain embodiments of the present description, the corresponding pixel of the image has a location that corresponds to a location of the pixel of the background image.

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37/190 [00136] The at least one processor may be further configured to determine a baseline that corresponds to an opening in the drip chamber.

[00137] The at least one processor may be further configured to determine whether each of the plurality of pixels of interest is within the subset of pixels if the respective pixel of the plurality of pixels has a contiguous path back to the baseline of the drop which forms in an opening of the drip chamber to determine whether the subset of pixels is within the plurality of pixels of interest corresponding to a drop.

[00138] The at least one processor may also be configured to: capture a first image using the image sensor; identify the drop within the first image and a predetermined band near the edge of the drop; initialize a background image by adjusting each pixel for the first image unless it is within the identified drop or the predetermined band near the edge of the drop; adjust the pixels within the drop region or within the predetermined band to a predetermined value; initialize a network of integers; and initialize a network of variances.

[00139] The at least one processor can still be configured to update the background image, the network of integers, and / or the network of variances using the image.

[00140] In certain embodiments of the present description, a flow meter includes an image sensor means and a flow rate estimator means. The image sensor means is for capturing a plurality of images from a drip chamber. The flow rate estimator means is to estimate the flow of fluid through the drip chamber using the plurality of images.

[00141] The flow rate estimator means may include a processor means for estimating the flow of fluid through the flow chamber.

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38/190 drip using the plurality of images.

[00142] The flow meter may further include a memory medium in operative communication with the processor medium to provide an operative set of instructions executable per processor to cause the processor medium to estimate the flow of fluid through the drip chamber using the plurality of images.

[00143] In certain embodiments of the present description, a flow meter includes: a memory medium that has a set of executable instructions per processor configured to be executed; and a processor means for executing the operating set of executable instructions per processor to implement a flow rate estimator means for estimating the flow of fluid through the drip chamber using the plurality of images.

[00144] In certain embodiments of the present description, a method includes: a step to capture a plurality of images from a drip chamber; and a step to estimate the fluid flow through the drip chamber using the plurality of images. The method can be implemented by an operating set of instructions executable per processor stored in a non-transitory memory and executed by at least one processor.

[00145] In certain embodiments of the present description, an apparatus includes: a coupler adapted to couple with a drip chamber; a support member operatively coupled to the coupler; an image sensor that has a field of view and is operatively coupled to the support member, in which the image sensor is positioned to see the drip chamber within the field of view; a valve configured to couple a fluid tube in fluid communication with the drip chamber, wherein the valve is configured to regulate the flow through the fluid tube to thereby regulate the flow of fluid through the drip chamber

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39/190 ment; and at least one processor operatively coupled to the image sensor to receive image data from it, wherein the at least one processor is configured to: capture a plurality of images from the drip chamber using the image sensor; estimating a volume growth rate of a drop within the drip chamber using the plurality of images; receiving a setpoint that corresponds to a fluid flow rate through the fluid tube; adjust a control system according to the estimated drop volume growth rate to achieve the set point; and outputting a control signal from the control system to a valve actuator to control the actuation of the valve according to the adjusted control system.

[00146] The device can include a readable memory per processor, non-transitory that has an operating set of executable instructions per processor stored in it. Processor-readable, non-transitory memory may be in operative communication with at least one processor so that the operating set of executable instructions per processor controls the operation of at least one processor.

[00147] The device may include memory readable by processor, non-transitory readable by at least one processor. Processor-readable, non-transitory memory may include an operating set of executable instructions per processor stored there configured to cause at least one processor, when executed: to capture the plurality of images from the drip chamber using the image sensor; estimate the rate of volume growth of the drop within the drip chamber using the plurality of images; receive the set point that corresponds to a fluid flow rate through the fluid tube; adjust the control system according to the drop volume growth rate and

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40/190 taken to reach the set point; and send the control signal from the control system to a valve actuator to control the valve actuation according to the adjusted control system.

[00148] The control system can be at least one of a proportional control system - integral, derivative, a proportional control system - integral, a proportional control system - derivative, proportional control system, an integral control system, a neural network control system, a fuzzy logic control system, and / or a bang-bang control system.

[00149] The control system can correlate the estimated drop volume growth rate with the fluid flow through the fluid tube.

[00150] The valve may include: an elongated support member, curved elastically deformable and having a first and second ends; and an opposite support member configured to position the fluid tube against the elongated support member, curved between the first and second ends, wherein the deformation of the elongated support member, curved by the movement of the first and second ends one in the direction of the another reduces an internal volume of the fluid tube. The actuator can be configured to move the first and second ends towards each other.

[00151] The valve can include: a first elongated support member that defines a length; and a second elongated support member defining a length, wherein the length of the second elongated support member is arranged in a spaced relationship with the length of the first elongated support member to cooperate with the first elongated support member to compress the tube. of fluid. The actuator can be in mechanical coupling with at least one of the first and second support members elongated to actuate the first and second support members

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41/190 elongated in the direction of each other to thereby compress the fluid tube disposed between them to regulate the flow of fluid within the fluid tube. The actuation of the actuator acts on the first and second elongated support members to regulate the flow of fluid inside the tube according to an approximate sigmoid curve.

[00152] The valve can include: a first elongated support member that defines a length; and a second elongated support member defining a length, wherein the length of the second elongated support member is arranged in a spaced relationship with the length of the first elongated support member to cooperate with the first elongated support member to compress the tube. of fluid. The actuator is in mechanical coupling with at least one of the first and second elongated support members to actuate the first and second elongated support members towards each other, thereby compressing the fluid tube disposed between them to regulate the flow of fluid inside the tube. The actuation of the actuator acts on the first and second elongated support members to regulate the flow of fluid inside the tube according to an approximate Gompertz curve.

[00153] The valve can include: a first elongated support member that defines a length; and a second elongated support member defining a length, wherein the length of the second elongated support member is arranged in a spaced relationship with the length of the first elongated support member to cooperate with the first elongated support member to compress the tube. of fluid. The actuator is in mechanical coupling with at least one of the first and second elongated support members to actuate the first and second elongated support members towards each other, thereby compressing the fluid tube disposed between them to regulate the flow of fluid inside the

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42/190 fluid. The actuation of the actuator acts on the first and second elongated support members to regulate the flow of fluid inside the tube according to an approximate generalized logistic function.

[00154] The valve can include: a first support member forms at least one of an arc, a plurality of arcs, a curve, a plurality of curves, an arcuate shape, a plurality of arcuate shapes, an S-shape, an C-shape, a convex shape, a plurality of convex shapes, a concave shape, and a plurality of concave shapes; and a second support member disposed in spaced relation with the first support member to cooperate with the first support member to compress the fluid tube along a length of the fluid tube at least substantially greater than the diameter of the fluid tube. fluid. The actuator is in mechanical coupling with at least one of the first and second support members to actuate the first and second support members towards each other, thereby compressing the fluid tube arranged between them to regulate the flow of fluid within of the fluid tube. The actuation of the actuator acts on the first and second support members to regulate the flow of fluid within the fluid tube according to an approximate non-linear function.

[00155] The valve can include: an elongated support member, curved elastically deformable and having a first and second ends; and an opposite support member configured to define a conduit with the elongated, curved support member. The conduit is defined between the elongated, curved support member and the opposite member. The fluid tube is disposed within the conduit and the deformation of the elongated support member, curved by the movement of the first and second ends towards each other reduces an internal volume of the fluid tube within the conduit.

[00156] The valve can be a reverse Bourdon tube valve

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43/190 coupled to the fluid tube to regulate the fluid flowing through the fluid path of the fluid tube.

[00157] The valve can include: a flexible first member; and a second flexible member operatively coupled to the first flexible member. The fluid tube can be arranged between the first and second flexible members. The first and second flexible members are configured to flex to thereby regulate the flow of fluid passing through the fluid tube, and the actuator is coupled to at least a first end of the first flexible member and a second end of the first flexible member .

[00158] The valve may include a first C-shaped member that defines internal and external surfaces; and a second C-shaped member that defines internal and external surfaces. At least one of the outer surface of the first C-shaped member and the inner surface of the second C-shaped member is configured to receive a fluid tube. The inner surface of the second C-shaped member is arranged in a spaced relationship to the outer surface of the first C-shaped member. The actuator is coupled to the first and second C-shaped members to bend the first and second shaped members of C to compress the fluid tube.

[00159] The valve can include: a first flexible plate; and a second flexible plate operatively coupled to the first flexible plate. The first and second flexible plates are configured to receive the fluid tube between them. The first and second flexible plates are also configured to flex to thereby regulate the flow of fluid that passes through the fluid tube. The actuator is attached to the first and second flexible plates to regulate the flow of fluid that passes through the fluid tube.

[00160] The valve can include: a first member in the form of

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44/190 curve that defines internal and external surfaces; and a second curved member defining internal and external surfaces. The inner surface of the second curved member is arranged in a spaced relationship to the outer surface of the first curved member with the fluid tube disposed between the first and second curved members, and the actuator is coupled to the first and second curved members to bend the first and second curved members to regulate the flow of fluid within the fluid tube.

[00161] The valve can include: a first curved member defining internal and external surfaces, the first curved member having a first and second receiving members at opposite ends of the first curved member; and a second curved member defines inner and outer surfaces, the second curved member having a first and second fasteners at opposite ends of the second curved member. The first receiving member of the first curved member is configured to engage the first fastener of the second curved member. The second receiving member of the first curved member is configured to couple the second fastener of the second curved member. The actuator is coupled to the first and second curved members to bend the first and second curved members to regulate the flow of fluid within the fluid tube disposed between them.

[00162] The valve may include: a first elongated support member, curved elastically deformable and having a first and second ends; and a second elongated, curved, elastically deformable member having a first and second ends, wherein the second elongated, curved support member is configured to position a tube against the first member of

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45/190 elongated, curved support, in which the deformation of the first and second elongated support members, curved by the movement of the first and second ends of the first elongated support member, curved towards each other reduces an internal volume of the fluid tube ; a first connector coupled to the first end of the first elongated, curved support member and coupled to the first end of the second elongated, curved support member; a second connector coupled to the second end of the first elongated, curved support member and coupled to the second end of the second elongated, curved support member, wherein the second connector defines a hole; a connecting member having one end coupled to the first connector and the other end configured for insertion into the hole of the second connector, wherein the connecting member defines a threaded rod at least along a portion thereof; and a button that has a ratchet configured to operate over the connecting member when moved from the other end of the connecting member towards the end of the connecting member, where the button is still configured to engage the threaded rod of the connecting member . The actuator can be attached to the button to rotate the button.

[00163] The valve can include: a base that defines a hole configured to receive the fluid tube; a plurality of fingers each having an end coupled to the base; and a ring configured to slide from the base and along the plurality of fingers. The movement of the base ring compresses the fingers against the fluid tube. The ring is configured to lock with friction against the plurality of fingers. The actuator is attached to the ring to slide the ring.

[00164] The valve can include: a conically formed member that has a surface to wrap the fluid tube around it; and a complementary member configured to couple the coni member

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46/190 specifically formed to compress the tube. The actuator is configured to compress the conically formed member against the complementary member to thereby compress the fluid tube.

[00165] The control system can be implemented in hardware, software, a combination of hardware and software, and / or by at least one operational amplifier.

[00166] The device may include a readable memory per processor, non-transitory, in which: the control system is implemented by an operating set of executable instructions per processor configured for execution by at least one processor, the operative set of instructions executable by processor is stored in processor-readable, non-transient memory, and processor-readable, non-transient memory is in operative communication with at least one processor to operatively communicate with the operating set of executable instructions per processor for at least one processor for execution for at least one processor.

[00167] The setpoint can be compared to a drop volume growth rate to adjust the control system. The setpoint can be compared to a drop volume growth rate to determine an error signal. The error signal can be the difference between the set point and the volume growth rate of the drop. The error signal can be passed through a signal processing device to generate the output signal. The signal processing apparatus can implement a proportional - integral - derivative controller with at least one non-zero gain parameter.

[00168] In another embodiment of the present description, an apparatus for regulating the flow of fluid includes an elongated, curved support member and an opposite support member. The support member elongates

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47/190 do, curved is elastically deformable and has a first and second ends. The first end is configured to hinge on the first and second dog bone connectors, and the second end is configured to hinge on the third fourth dog bone connectors. The opposite support member is configured to position a tube against the elongated support member, curved between the first and second ends so that the deformation of the elongated support member, curved by the movement of the first and second ends towards each other reduces an internal cross section along a length of the tube. The first end of the opposite support member is configured to hinge on the first and second dog bone connections, and a second end of the opposite support member is configured to hinge on the third and fourth dog bone connections.

[00169] The first end of the elongated, curved support member can include a coupling finger configured to attach a rack. The second end of the elongated, curved support member can be configured to pivot. The apparatus may include a button attached to the end of the elongated, curved support member for moving the rack.

[00170] In yet another embodiment of the present description, a flow meter includes a coupler, a support member, an image sensor, a laser, and at least one processor. The coupler is adapted to couple with a drip chamber. The support member is operatively coupled to the coupler. The image sensor has a field of view and is operatively coupled to the support member, and the first image sensor is configured to see the drip chamber within the field of view. The laser is configured to illuminate the optical light over the optics assembly

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Binary 48/190.

[00171] The at least one processor is operatively coupled to the image sensor so that: (1) the at least one processor receives data from the image sensor that has at least a portion of the background pattern represented therein; and (2) the at least one processor estimates at least one liquid parameter within the drip chamber using the image data.

[00172] In yet another embodiment of the present description, a flow meter includes a coupler, a support member, a first and second electrodes, and at least one processor. The coupler is adapted to couple with a drip chamber. The support member is operatively coupled to the coupler. The first electrode is configured to connect to a fluid line in fluid communication with the drip chamber. The second electrode is configured to engage the fluid line in fluid communication with the drip chamber.

[00173] The at least one processor is operatively coupled to the first and second electrodes to measure a capacitance between them, and the at least one processor is configured to monitor the capacitance. The at least one processor can be configured to determine whether a fluid condition exists within the drip chamber using the monitored capacitance.

[00174] In yet another embodiment of the present description, a safety valve includes a housing, first and second occlusion arms, first and second axes, and a spring. The housing is configured to attach a tube. The first and second occlusion arms are coupled together. The first axis is coupled hinged to an end furthest from the first occlusion arm. The second axis is coupled articulated to an end farthest from the second occlusion arm. The spring is

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49/190 disposed adjacent to the first and second occlusion arms on an opposite side of the tube configured to spring load the first and second occlusion arms. The safety valve is configured to discharge the spring and occlude the tube when the first and second occlusion arms articulate away from the spring along its joint joint by a predetermined amount. A solenoid can be used to couple the first and second occlusion arms to discharge the spring.

[00175] In yet another embodiment of the present description, an apparatus includes a coupler, a support member, and at least one processor. The coupler is adapted to couple with a drip chamber. The support member is operatively coupled to the coupler. The image sensor has a field of view and is operatively coupled to the support member. The image sensor is configured to see the drip chamber within the field of view. The at least one processor is operatively coupled to the image sensor to receive its image data, and the at least one processor is configured to: (1) capture an image from the drip chamber; (2) positioning a template within the captured image in a first position; (3) averaging the pixels within the template to determine a first average; (4) move the template to a second position; (5) calculating the average of pixels within the template to determine a second average; (6) determine that the template is located on the edge of a drop if the difference between the second average and the first average is greater than a predetermined limit value; (7) and correlate the second position with a drop volume.

[00176] In yet another embodiment of the present description, a method implemented by at least one processor that executes an operative set of executable instructions per configured processor

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50/190 to be performed by at least one processor to estimate a flow rate is described. The method includes: (1) capturing an image from the drip chamber; (2) positioning a template within the captured image in a first position; (3) averaging the pixels within the template to determine a first average; (4) move the template to a second position; (5) averaging the pixels within the template to determine a second average; (6) determine that the template is located on the edge of a drop if the difference between the second average and the first average is greater than a predetermined limit value; and (7) correlating the second position with a drop volume.

[00177] In yet another embodiment of the present description, a flow meter includes a coupler, a support member, a modular backlight assembly, an image sensor, and at least one processor. The coupler is adapted to couple a drip chamber. The support member is operatively coupled to the coupler. The adjustable backlight set is configured to provide a first backlight and a second backlight. The image sensor has a field of view and is operatively coupled to the support member. The image sensor is configured to see the drip chamber within the field of view and the adjustable backlight assembly. The at least one processor is operatively coupled to the image sensor and the modulating backlight set so that the at least one processor receives data from the image sensor that has at least a portion of the modulating backlight set represented therein. , and the at least one processor is configured to modulate the backlight assembly for the first backlight when estimating a drop size to modulate the backlight assembly for the second backlight. The first backlight can be a backlight

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51/190 diffuser that has no pattern and the second backlight can be a diffuser backlight that has a striated pattern.

[00178] In yet another embodiment of the present description, a tube restorer includes a first and a second gear. The second gear is arranged staggered against the first gear. The first and second gears define a space along radial portions of the first and second gears to allow a tube to flex between them. The first and second gears are further configured to restore the tube when rotated so that the space is not positioned between the first and second gears.

[00179] In yet another embodiment of the present description, a valve includes a first second metal strip, and a first and second guide members. The first guide member is coupled to the outermost ends of the first and second metal strips. The second guide member is attached to the ends closest to the first and second metal strips. The first and second metal strips are configured to compress a tube when the ends furthest from the first and second metal strips are actuated towards the ends closest to the first and second metal strips. The valve may further include a cord (for example, a metal cord or a cord made of any other material) braided through the first and second metal strips to spiral around the tube.

[00180] In yet another embodiment of the present description, a valve includes first and second shells configured to provide a cavity between the first and second shells. The first and second shells are configured to receive a tube between them and inside the cavity. The valve also includes a bladder arranged inside the cavity and a pump configured to inflate or deflate the

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52/190 bladder to regulate the flow of fluid inside the tube.

[00181] In yet another embodiment of the present description, an apparatus includes a coupler, a support member, an image sensor, and at least one processor. The coupler is adapted to couple in the drip chamber. The support member is operatively coupled to the coupler. The image sensor has a field of view and is operatively coupled to the support member. The image sensor is configured to see the drip chamber within the field of view.

[00182] The at least one processor is operatively coupled to the image sensor to receive its image data and is configured to: (1) capture a first image; (2) create a first image with a limit of the first image by comparing each pixel of the first image with a limit value; (3) determining a set of pixels within the first bounded image connected to a predetermined set of pixels within the first bounded image; (4) filter all remaining pixels of the first bounded image that are not within the set of pixels, the filter operates on a pixel by pixel basis within the time domain to generate a first filtered image; (5) removing the determined pixels not being part of a drop of the first bounded image using the first filtered image to generate a second image; (6) determining a second set of pixels within the second image connected to a predetermined set of pixels within the second image to generate a third image, the third image identifies the second set of pixels within the second image; (7) determining a first droplet length by counting the number of lines containing pixels that correspond to the second set of pixels within the third image, the first length corresponding to an estimated first droplet size; (8) update a useful background image

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53/190 using the first image; (9) create a second bounded image by comparing the first image with the background image; (10) adding the lines of the second bounded image to create a plurality of sums of lines, each sum of lines corresponds to a line of the second bounded image; (11) start at a line position of the second bounded image that has a first sum of the plurality of sums that corresponds to the first length; (12) increment the line position until the line position corresponds to a corresponding line sum that is zero; (13) determining a second length that is equal to the present line position, the second length corresponding to an estimated second droplet size; and (14) averaging the first and second lengths to determine an average length, the average length corresponding to an estimated third drop size.

[00183] In yet another embodiment of the present description, a method implemented by at least one processor that executes an operative set of executable instructions per processor configured to be executed by at least one processor to estimate a flow rate includes: (1) capturing a first image; (2) create a first image with a limit of the first image by comparing each pixel of the first image with a limit value; (3) determining a set of pixels within the first bounded image connected to a predetermined set of pixels within the first bounded image; (4) filter all remaining pixels of the first bounded image that are not within the set of pixels, the filter operates on a pixel by pixel basis within the time domain to generate a first filtered image; (5) removing the determined pixels not being part of a drop of the first bounded image using the first filtered image to generate a second image; (6) determine a second set of pixels within the second connected image

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54/190 used a predetermined set of pixels within the second image to generate a third image, the third image identifies the second set of pixels within the second image; (7) determining a first droplet length by counting the number of lines containing pixels that correspond to the second set of pixels within the third image, the first length corresponding to an estimated first droplet size; (8) update a background image using the first image; (9) create a second bounded image by comparing the first image with the background image; (10) adding the lines of the second bounded image to create a plurality of sums of lines, each sum of lines corresponds to a line of the second bounded image; (11) start at a line position of the second boundary image that has a first sum of the plurality of sum that corresponds to the first length; (12) increment the line position until the line position corresponds to a corresponding line sum that is zero; (13) determining a second length that is equal to the present line position, the second length corresponding to the second estimated drop size; and (14) averaging the first and second lengths to determine an average length, the average length corresponding to an estimated third drop size.

[00184] In yet another embodiment of the present description, a flow meter that includes a coupler, a support member, first and second loop antennas, and at least one processor. The coupler is adapted to couple with a drip chamber. The support member is operatively coupled to the coupler. The first loop antenna is disposed adjacent to a fluid line in fluid communication with the drip chamber. The second loop antenna is disposed adjacent to the fluid line. The at least one processor is operatively coupled to the first and second

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55/190 loop antennas to measure a magnetic coupling between them. The at least one processor is configured to monitor the magnetic coupling between them to determine whether a flow condition exists within the drip chamber.

[00185] In yet another embodiment of the present description, a method implemented by an operative set of instructions executable per processor includes: (1) determining a plurality of points of interest in an image; (2) randomly select N points of interest from the plurality of points of interest; and / or (3) identify a single, singular, geometric feature characterized by N parameters that correspond to N points of interest.

[00186] In yet another embodiment of the present description, a system includes a non-transitory memory and one or more processors. Non-transitory memory has a plurality of instructions stored there. The one or more processors are in operative communication with the non-transitory memory to execute the plurality of instructions. The plurality of instructions is configured to make the processor: (1) determine a plurality of points of interest in an image; (2) randomly select N points of interest from the plurality of points of interest; and / or (3) identify a single, singular, geometric feature characterized by N parameters that correspond to N points of interest.

[00187] In certain embodiments of the present description the flow of fluid is controlled by a valve that deforms a tube using a plunger, a rigid housing, and substantially incompressible filling. The tube is positioned within a defined channel in the filling. A rigid housing creates a wrap around the filling, the housing has a hole for the plunger to enter the housing and couple the filling. An actuator is connected to the plunger, controlling the movement of the plunger. The plunger force coupling the

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56/190 filling is transferred to the tube, and causes the tube to deform different amounts depending on how far the plunger is actuated into the housing.

[00188] The filling can have multiple layers of different stiffness. The softest of the layers can be a material that has a shore OO hardness of approximately 20 to approximately 25. The most rigid of the layers can be a material that has a shore OO hardness of approximately 15.

[00189] The actuator can be a linear actuator that is designed to actuate the plunger in, out, or both in and out of the housing.

[00190] In another embodiment of the present description, the housing may include a first and second connected shell portions articulated to each other. The portions are connected to allow opening and closing as a shell. A latch is connected to the housing to lock the shell portions in a secure closed position. The first shell portion defines a hole sized to accept the plunger. A guide connected to the first shell portion and the actuator is configured to guide the plunger actuated through the hole in the first shell portion.

[00191] In another embodiment of the present description, the first and second shell portions each define a portion of the cavity created when the portions are in the closed position. The filling located within the shell portions has at least two layers of different hardness, and four layers in total. The first and second layers are within the cavity of the first portion, and the third and fourth layers are within the second cavity of the portions. The first and fourth layers are arranged on the inner surface of their respective shell portions. The second and third layers define a channel to guide the tube being valved and

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57/190 are arranged on the first and fourth layers respectively. The material of the second layer is harder than the material of the first and the material of the third layer is harder than the material of the fourth. [00192] In yet another embodiment of the present description, a guide is connected to the first shell portion and the actuator to guide the plunger through a hole in the first shell portion. At least one spring is connected to the guide and guide and plunger, the spring exerts a force by pulling the plunger towards the housing.

[00193] In yet another modality of the present description, the actuator is configured to be controlled by a monitoring client.

[00194] Another embodiment of the present description involves a system for controlling fluid flow through a drip chamber. The system includes a drip chamber coupler, a support member, an image sensor, a valve, and at least one processor. The drip chamber coupler secures the drip chamber, orienting it vertically and in a position that can be seen by the image sensor. The support member is connected to the drip chamber coupler and the image sensor is operatively attached to the support member. The image sensor is positioned to have the drip chamber within its field of view. The valve is fluidly coupled to the drip chamber and has the ability to control the flow through the drip chamber. The valve comprises a housing, a filler, a plunger, and an actuator. The housing surrounds a tube that is in fluid communication with the drip chamber, fixed inside the housing is the filling. The accommodation can include a first and a second shell portion. The first shell portion defines a hole and is connected to a guide configured to guide the plunger through the hole. The filling has at least two

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58/190 layers of different stiffness to help uniform and consistent tube deformation. The plunger is configured to couple the filler through a hole in the housing and operationally deform the tube inside the filler. The actuator is operatively connected to the plunger and configured to actuate the plunger. The at least one processor is in communication with the image sensor and the actuator. The at least one processor is configured to receive the image data from the image sensor, use the image data to estimate at least one parameter of the liquid inside the chamber, and then actuate the plunger to achieve a target parameter. The parameter can be the formation of the liquid, the volume of the liquid, or the shape of the liquid. The target parameter can be a target flow rate or a target drop growth rate. The processor can determine the existence of a flow condition using the image data.

[00195] A background pattern can be positioned within the field of view of the image sensor, with the drip chamber positioned between the image sensor and the background pattern.

[00196] The housing may include a first and second shell portion with the first connected portion hinged on the second portion. The portions are connected in a way that allows an open position and a closed position that defines a cavity. The first shell portion defines a first portion of the cavity and the second shell portion defines a second portion of the cavity. [00197] The at least two layers of different hardness of the filler may include a first, second, third, and fourth layer. The first and second layers being located within the first portion of the cavity, and the third and fourth layers being located within the second portion of the cavity. The first and second layers are arranged on the internal surfaces of their

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59/190 respective shell portion, the second layer is arranged on top of the first layer, and the third layer is arranged on top of the fourth layer. The second and third layers are more rigid than the first and second layers. A channel is defined in the second and third layers to guide the tube through the filling.

[00198] In certain embodiments of the present description, a method includes capturing multiple images from a drip chamber using an image sensor, estimating a flow rate through the image drip chamber using a processor, receiving a desired flow rate from a user, compare the estimated flow rate with the desired flow rate using a processor, determine the magnitude and direction of valve actuation to achieve the desired flow rate, and actuate a valve according to the determined magnitude and direction, to achieve the desired flow rate. Operating the valve may involve adjusting the pressure around a flexible tube that has a lumen in fluid communication with the drip chamber to deform the tube and modify the shape of the lumen. Pressure adjustment can be made possible by arranging a rigid housing around the defined section of the tube, closing a substantially incompressible filling inside the housing, and coupling the filling with a plunger thereby increasing the pressure within the housing resulting in deformation of the pipe .

[00199] The method may also include communicating the estimated flow rate to a fluid monitoring client.

[00200] The method can also include monitoring for unplanned events and stopping the flow when unplanned events occur. [00201] The method may also include deforming a flexible tube in fluid communication with the drip chamber to reduce its lumen size during the process of installing or removing the

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60/190 tube of an apparatus that performs this method. Once the process of installing or removing the tube is complete, the compressive force is moved from the tube allowing the lumen created by the tube to revert to substantially its initial size.

[00202] In certain embodiments of the present description, a system for controlling the flow through a drip chamber includes a drip chamber case, an image forming device, a flexible tube, and a valve. The drip chamber case receives and attaches a drip chamber. The imaging device is configured to capture images from the drip chamber and create image data from the captured images. The flexible tube is connected to the drip chamber and the lumen defined by the tube is in fluid communication with the drip chamber. The valve is axially arranged around a portion of the flexible tube and controls the flow through the tube and finally the drip chamber. The valve includes a first and second connected lining components hinged to one another and aligning complementarily to form a wrap when in a closed position. Inlet and outlet holes are defined in the valve liner when it is closed and a plunger hole is defined in the first liner component. A male latch component is connected to the first housing component opposite the hinge connection and a female latch component is coupled to the second housing component opposite the hinge connection. A substantially incompressible filler is closed within the liner. The filling defines a conduit sized for a specific pipe, which connects the inlet and outlet holes of the valve liner. There are a plurality of variations in the fill stiffness. The portion of the filling closest to the tube may be more rigid than the surrounding filling

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61/190 te. The plunger is longitudinally aligned with the plunger bore and attached to the actuator. The actuator is configured to actuate the plunger in and out of the plunger bore to couple the filling. Changes in displacement by the plunger alter the forces on the section of the tube within the liner resulting in the lumen changing in size. The plunger head area may be smaller than the longitudinal cross section of the lumen disposed within the housing. [00203] The system may also include a safety cut, the safety cut comprises occlusion arms, at least one spring, and a trigger mechanism. The occlusion arms are configured to compress the tube in a stop which reduces the area of the lumen defined by the tube. The at least one spring maintains a constant pressure on the occlusion arms, forcing them towards the stop. The occlusion arms are restrained behind the stop by a firing mechanism that can release the occlusion arms when fired. The triggering mechanism can use a magnetic force to restrict the occlusion arms, created from adjacent magnets or a magnet inside a coil. A first and second magnets can be configured to allow the alignment of opposite poles to produce an attractive magnetic force. A solenoid can be used to apply force to the firing mechanism by releasing the occlusion arms. Current-responsive material can be used to apply force to the solenoid. If the first and second magnets are used, they can be reconfigured to align equal poles and apply a repulsive magnetic force to the trigger mechanism. A safety sensor can be used to detect unplanned events and transmit the data of the unplanned event to a processor that can couple the solenoid and release the occlusion arms.

[00204] The system can also include at least one processor,

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62/190 the processor can receive image data from the image forming device, estimate a flow rate based on the image data, compare the estimated flow rate with a desired flow rate, and adjust the actuator to create the rate desired flow rate.

[00205] The system may also include a wrap liner, the wrap liner comprising a body and a hinged connected door on the body. When in the closed position, the door and the body create a wrap that houses the valve. An arm can be hingedly connected to the door on its first side and the female latch component on its second side. The arm is configured to unlock and open the two parts of the valve housing when the door is open, and to lock and close the two parts of the valve housing when the door is closed.

[00206] The system may also include an arm with a first end hinged to the door and a second end operably configured to reset the safety cut to a free flow position when the door is open.

[00207] The system can also include a valve that has at least one cutting spring, a threaded drive shaft, and a threaded coupling member. The at least one cutting spring exerts a force on the piston in the direction of the valve housing. The threaded drive shaft has a first end attached to the actuator output shaft and a second opposite end connected to the plunger. The connection between the piston and the drive shaft allows the piston to rotate freely with respect to the drive shaft. The threaded coupling member is operatively connected to the valve liner and is configured to couple the threads on the drive shaft. This allows the actuator to control the position of the plunger by turning the threaded drive shaft. The coupling member has the ability to disengage from the threads

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63/190 cas on the drive shaft leaving only the cutting spring to force the plunger in the direction of the valve housing thereby deforming the tube. A spring can be used to force the coupling member towards the drive shaft. The system can also incorporate an arm with a hinged first end of the wrap liner door and a second end configured to push the threaded coupling member away from the drive shaft when the door is open.

[00208] In another embodiment of the description described, an apparatus includes an apparatus casing, a drip chamber, an image sensor, and a valve. The apparatus cover comprises a body and a door which are connected to each other, forming a wrapper when in a closed configuration. The drip chamber is connected to the outside of the casing body. The image sensor is also attached to the outside of the casing body and oriented so that the drip chamber is within your field of view. The valve is arranged within the apparatus casing and includes a first and second valve housing components, male and female latch components, a filler, a plunger, and an actuator. The first and second valve housing components are connected hinged to further align and form a wrap when in a closed position. An inlet hole and an outlet hole are defined when the housing is in a closed position. The first valve housing component has a plunger hole to allow the plunger to enter the liner. The male latch component is attached to the first valve housing component and the female latch component is attached to the second valve housing component, both connected to their respective housing components in a location affixed to the joint. O

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64/190 filling is made of a substantially incompressible material and is closed within the valve liner. A conduit sized for a specific pipe is defined inside the filling and connects the inlet and outlet holes of the valve liner. The filling is made up of multiple layers of varying stiffness, the filling layers near the duct can be more rigid than the surrounding layers. The plunger is connected to the actuator and is longitudinally aligned with the plunger bore. The actuator is configured to force the plunger through the plunger bore. The plunger head may have a smaller area than the longitudinal cross section of the lumen disposed within the housing.

[00209] The device can also include a user input device over the device casing door, allowing users to manually enter information, including the desired flow rate, into the device. The device may also include a display over the device cover door configured to display infusion information. A touch screen display can be used in conjunction with or in place of buttons to allow a user to enter information on the device.

[00210] The device can also include a processor in communication with the image sensor and the actuator. The processor receives data from the image sensor, estimates the flow rate based on the image data, compares the estimated flow rate with a desired flow rate, and adjusts the actuator to achieve the desired flow rate.

[00211] The apparatus may also include a safety cut which includes occlusion arms, a stop, at least one spring, and a trigger mechanism. The springs are operatively connected to the occlusion arms, forcing them towards the stop with sufficient strength to compress a tube against the stop and reduce the size

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65/190 of the lumen formed inside the tube. The trigger mechanism releases the occlusion arms allowing them to compress the tube when the mechanism is triggered. A solenoid can be used to trigger the safety cut by applying force to the occlusion arms. A safety sensor can be used in conjunction with a processor to detect unplanned events and couple the solenoid to trigger the release of the occlusion arms.

[00212] In certain embodiments of the description described the female latch component is a connected lever hinged on the valve liner at a point offset from its end, this creates a lever having an inlet end and an opposite outlet end. The male latch component is a flange. The latch components are positioned to allow the outlet end of the female component to engage the opposite side of the flange when the valve liner is in a closed position. The lever applies force to the flange by compressing the first and second valve liner components together when rotated in the direction that pushes the outlet end of the lever into the flange. A guide arm can be hingedly hinged to the apparatus casing door at its first end, and at the entry end of the female latch lever at its second opposite end. When the door is closed, the guide arm engages the outlet end of the lever with the male latch flange and rotates the lever to compress the valve liner components together.

[00213] Certain modalities of the described description include a compression flap and a wedge. The compression flap is arranged inside an opening in the body of the device cover. The flap has a compressive force large enough to deform an IV tube positioned between the flap and the body of the apparatus cover. THE

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66/190 wedge protrudes out of the door and is positioned to couple the flap when the door is closed, relieving the compressive forces of the flap against the apparatus casing body or the tube between them.

[00214] In another embodiment of the description described, the valve may include at least a cutting spring, a threaded drive shaft, and a threaded coupling member. The at least one cutting spring exerts a force by pulling the plunger and the actuator towards the valve housing. The threaded drive shaft has a first end attached to the actuator output shaft and a second opposite end connected to the plunger. The connection between the piston and the drive shaft allows the piston to rotate freely with respect to the drive shaft. The threaded coupling member is operatively connected to the valve liner and is configured to couple the threads on the drive shaft. This allows the actuator to control the position of the plunger by turning the threaded drive shaft. The coupling member has the ability to uncouple the threads on the drive shaft, allowing the cutting spring to force the plunger towards the valve liner thereby deforming the tube. A spring can be used to force the coupling member towards the drive shaft. The system may also incorporate an arm with a first end hinged to the wrap liner door and a second end configured to push the threaded coupling member away from the drive shaft when the door is open.

[00215] In another embodiment of the description, an apparatus includes a first and second metal structures and an impedance matching structure coupled with the first and second metal structures, with the impedance matching structure configured to essentially match a desired interrogator frequency. . O

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67/190 apparatus also includes a short mechanism coupled with the first and second metallic structures.

[00216] The apparatus may include metal structures that are pre-existing components of a set. The apparatus may also include an inductor, a capacitor, or a combination of an inductor and a capacitor as the impedance matching structure. The shorting mechanism can be a transistor or a switch and can be controlled by a microprocessor.

[00217] The apparatus may also include a low-pass filter coupled with the first and second metallic structures and which has a cutoff frequency sufficiently below the frequency of a desired interrogator.

[00218] In other embodiments of the present description, a method includes coupling a first and a second metallic structure to an impedance matching structure, with the impedance matching structure configured to essentially match a desired interrogator frequency. The method also includes shorting the first and second coupled metal structures.

[00219] In other embodiments of the present description, the method may also include coupling a low-pass filter with the first and second metallic structures. The short can be controlled by a microprocessor.

[00220] In another embodiment of the present description, a system for regulating fluid flow includes: a fluid reservoir for infusing the fluid contained therein in a patient; a drip chamber in fluid communication with the fluid reservoir, in which the drip chamber is configured to allow a drop of fluid to exit the fluid reservoir and travel through the drip chamber; a backlight arranged close to the drip chamber so that the backlight comes from at least

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68/190 partial illumination of the drip chamber; a valve configured to regulate the fluid flowing from the drip chamber to the patient; and a flow meter for monitoring the flow rate of the fluid passing through the drip chamber, the flow meter including: an image sensor configured to capture an image of the drip chamber; a processor configured to determine whether the image captured from the drip chamber contains a match to a template; and a set of executable instructions per processor configured to apply a turbidity function to the image captured by the drip chamber image sensor so that the processor can determine whether the captured image contains a match with the template.

[00221] The turbidity function can be a low-pass filter, the set of executable instructions per processor configured to apply the low-pass filter to the image captured by the image sensor in a vertical or horizontal direction. The low-pass filter may include a Gaussian Turbidity function. [00222] The turbidity function can be a low-pass filter, the set of executable instructions per processor configured to apply the low-pass filter to the image captured by the image sensor in both a vertical and horizontal direction. The low-pass filter includes a two-dimensional Gaussian Turbidity function. The template includes at least a partial image of a drop of fluid that forms inside the drip chamber. The captured image may include an image of the drip chamber that is at least partially illuminated by the backlight.

[00223] The desired pattern can include at least a partial image of a drop of fluid that forms inside the drip chamber, the drop being at least partially illuminated by the backlight. The turbidity function filters the captured image so that

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69/190 the processor can determine if the captured image contains a match with the template. The captured image is filtered to eliminate a number of details that include images of at least condensation or spatter inside the drip chamber. [00224] In another embodiment, a method for filtering a captured image from a drip chamber configured to allow a drop of fluid to fall into the drip chamber, the method comprising: capturing an image from the drip chamber with an image sensor ; determine whether the captured image contains a visual obstruction; apply a turbidity function to the captured image, the turbidity function configured to eliminate a number of details in the captured image; and determine if the captured image contains a match with a template.

[00225] The desired pattern can include at least a partial image of a drop of fluid inside the drip chamber. The turbidity function can be a low-pass filter, the low-pass filter being applied either in a vertical or a horizontal direction. The low-pass filter can include a one-dimensional Gaussian Turbidity function. The turbidity function can be a low-pass filter, the low-pass filter being applied in both a horizontal and a vertical direction. The low-pass filter may include a two-dimensional Gaussian Turbidity function. The amount of detail eliminated can include images of a condensation or spatter inside the drip chamber.

[00226] In another embodiment, a method for capturing an image from a drip chamber, the method comprising: illuminating at least a portion of a drip chamber; capture an image from the drip chamber with an image sensor; determine if there is a visual obstruction in the captured image

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70/190 using a processor operatively coupled to the image sensor; apply a turbidity function, using the processor, to the captured image to filter the captured image when determining that there is a visual obstruction in the captured image; and determine, using the processor, if there is a match with a template in the captured image.

[00227] The template can include at least a partial image of a drop of fluid inside the drip chamber. The turbidity function can be a low-pass filter, the processor applying the low-pass filter to the captured image or in a horizontal or vertical direction. The low-pass filter can include a one-dimensional Gaussian Turbidity function. The turbidity function can be a low-pass filter; the processor applying the low-pass filter to the captured image in both a horizontal and a vertical direction. The low-pass filter may include a two-dimensional Gaussian Turbidity function.

BRIEF DESCRIPTION OF THE DRAWINGS [00228] These and other aspects will become more apparent from the following detailed description of the various modalities of this description with reference to the drawings in which:

[00229] Figure 1 shows a block diagram of a system for regulating fluid flow according to an embodiment of the present description;

[00230] Figure 2 shows a flow chart of a method for exposing an image sensor according to an embodiment of the present description;

[00231] Figure 3 shows a time diagram illustrating an embodiment of the method of Figure 2 according to an embodiment of the present description;

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71/190 [00232] Figures 4A-4B show illustrations of image data (i.e., images) captured by a drip chamber flow meter to illustrate a modality of the method for exposing an image sensor in Figure 2 accordingly with the time diagram of Figure 3 according to an embodiment of the present description;

[00233] Figure 5 shows a diagram of a flow meter and valve that are integrated together for coupling to a drip chamber and an IV bag according to an embodiment of the present description;

[00234] Figure 6 is a block diagram of a flow meter image forming system to form an image of a drip chamber according to an embodiment of the present description;

[00235] Figure 7 is a graphic illustration of an image captured by the image sensor of the system of Figure 6 according to an embodiment of the present description;

[00236] Figure 8 is a block diagram of a flow meter image forming system to form an image of a drip chamber using a background pattern according to an embodiment of the present description;

[00237] Figure 9 is a graphic illustration of an image captured by an image sensor of a flow meter described herein when a free flow condition exists according to one embodiment of the present description;

[00238] Figure 10 is a graphic illustration of an image captured by a flow meter image sensor for use as a background image in accordance with an embodiment of the present description;

[00239] Figure 11 is a graphic illustration of an image captured by an image sensor when drops are being formed

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72/190 inside a drip chamber according to an embodiment of the present description;

[00240] Figure 12 is a graphic illustration of an image captured by an image sensor for use as a background image according to an embodiment of the present description;

[00241] Figure 13 is a graphic illustration of a difference between the images in Figures 11 and 12 with further processing according to an embodiment of the present description;

[00242] Figure 14 is a graphical representation of part of the image processing performed using Figures 11-13 to determine whether the free flow condition exists in accordance with an embodiment of the present description;

[00243] Figure 15 is a graphic illustration of an image captured by the image sensor when a free flow condition exists in accordance with an embodiment of the present description;

[00244] Figure 16 is a graphic illustration of an image captured by the image sensor for use as a background image according to an embodiment of the present description;

[00245] Figure 17 is a graphical illustration of a difference between the images in Figures 15 and 16 with some additional processing for use in detecting a free flow condition according to an embodiment of the present description;

[00246] Figure 18 is a graphical representation of part of the image processing performed using Figures 15-17 to determine whether the free flow condition exists according to one embodiment of the present description;

[00247] Figure 19 illustrates a template for pattern matching to determine if the free flow condition exists according to one embodiment of the present description;

[00248] Figure 20 is a graphic illustration of a difference between the

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73/190 reference image and an image containing a flow processed with edge detection and line detection for use in detecting a free flow condition according to an embodiment of the present description;

[00249] Figure 21 is a graphic illustration of an image of a drip chamber captured by an image sensor when a free flow condition exists in accordance with an embodiment of the present description;

[00250] Figure 22 is a block diagram of an image formation system for use with a flow meter that has a stripped background pattern and a light source that shines on the strips from an adjacent location for a sensor. image according to an embodiment of the present description;

[00251] Figure 23 is a block diagram of an image formation system for use with a flow meter that has a stripped background pattern and a light source that shines on the strips behind the relative pattern background to an opposite end of an image sensor according to an embodiment of the present description;

[00252] Figure 24 illustrates an image of an image sensor when a drop distorts the background pattern of Figure 23 according to an embodiment of the present description;

[00253] Figure 25 is a block diagram of an image formation system for use with a flow meter that has a checkered pattern background and a light source that shines on the strips behind the background pattern with respect to an opposite end of an image sensor according to an embodiment of the present description;

[00254] Figure 26 shows an image of the image sensor in Figure 25 when a drop distorts the background pattern according to

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74/190 an embodiment of the present description;

[00255] Figures 27-28 show a flow chart illustration of a method for estimating a drop volume within a drip chamber according to an embodiment of the present description;

[00256] Figures 29-31 illustrate images used or generated by a flow meter to estimate a drop volume within the drip chamber using the method illustrated by Figures 2728 according to an embodiment of the present description;

[00257] Figure 32 shows a pseudocode for identifying a plurality of pixels of interest according to the method of Figures 27-28 according to an embodiment of the present description;

[00258] Figures 33-36 illustrate additional images used or generated by a flow meter to estimate a drop volume within a drip chamber using the method illustrated by Figures 27-28 according to an embodiment of the present description;

[00259] Figure 37 shows a pseudocode for determining a subset of pixels within the plurality of pixels of interest corresponding to a drop according to an embodiment of the present description;

[00260] Figure 38 shows a ray diagram illustrating the diameter of a turbidity circle to illustrate aspects of an image sensor of an image formation system described here according to an embodiment of the present description;

[00261] Figure 39 is a graph illustrating a turbidity circle calculated for a variety of lens to focal plane separations and lens to image separations for an image sensor of an image forming system described here according to an embodiment of this description;

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75/190 [00262] Figure 40 is a graph illustrating the turbidity circle divided by a pixel size when a 20mm focal length lens from an image sensor of an image formation system described here is used accordingly with an embodiment of the present description;

[00263] Figure 41 is a graph illustrating the turbidity circle divided by a pixel size when a 40mm focal length lens from an image sensor of an image formation system described here is used according to one modality of this description;

[00264] Figure 42 shows a table illustrating corresponding fields of view around the optical geometric axis for the corners of two configurations of an image formation system described here according to an embodiment of the present description;

[00265] Figure 43 shows a flow meter coupled to a drip chamber according to an embodiment of the present description;

[00266] Figure 44 shows the flow meter and drip chamber of Figure 43 with the door open according to an embodiment of the present description;

[00267] Figure 45 shows a flow meter coupled to a drip chamber according to an embodiment of the present description;

[00268] Figure 46 shows a flow meter and a squeeze valve coupled to the flow meter body to control the flow of fluid to a patient according to an embodiment of the present description;

[00269] Figure 47 shows an enlarged view of the pinch valve that is coupled to the body of the flow meter of Figure 46 according to an embodiment of the present description;

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76/190 [00270] Figure 48 shows a flow meter and a pinch valve in which the flow meter includes two image sensors according to another embodiment of the present description;

[00271] Figure 49 shows a flow meter and a valve that includes two elongated support members, curved to control the flow of fluid to a patient according to an embodiment of the present description;

[00272] Figures 50A-50B show enlarged views of the valve of Figure 49 according to an embodiment of the present description;

[00273] Figures 51A-51D show several views of a flow meter with a monitoring client, a valve, a drip chamber, an IV pouch and a fluid tube in which the flow meter includes a receiving portion for receiving the valve according to an embodiment of the present description;

[00274] Figures 52A-52D show several views of another flow meter with a valve, a drip chamber, and a tube in which the flow meter has a receiving portion for receiving the valve in accordance with an embodiment of the present description ;

[00275] Figure 53A shows another view of the valve of Figures 51A51D and 52A-52D according to an embodiment of the present description;

[00276] Figures 53B-53C show two exploded views of the valve of Figure 53A according to an embodiment of the present description;

[00277] Figure 54 shows the valve of Figure 53 in manual use according to an embodiment of the present description;

[00278] Figure 55 shows a valve that includes two flexible members according to an embodiment of the present description;

[00279] Figures 56A-56C show several views of a valve that has two elongated support members, curved with one of

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77/190 elongated support members having a plurality of edges adapted to couple a tube according to an embodiment of the present description;

[00280] Figures 57A-57C show several views of a valve that has a ratchet that couples a connecting member according to an embodiment of the present description;

[00281] Figures 57D-57E show two exploded views of the valve of Figures 57A-57C according to an embodiment of the present description;

[00282] Figures 58A-58D show several views of a valve having two elongated support members, a connecting member, and a screw-type actuator according to another embodiment of the present description;

[00283] Figures 59A-59C show several views of a valve body according to an embodiment of the present description;

[00284] Figures 59D-59G show several views of a button for use with the body shown in Figures 59A-59C according to an embodiment of the present description;

[00285] Figure 59H shows the assembled valve that includes the body shown in Figures 59A-59C coupled to the button in Figures 59D59G according to an embodiment of the present description;

[00286] Figure 60 shows a valve having a guide protuberance according to an embodiment of the present description;

[00287] Figure 61 shows a motor and a valve fixing structure for coupling to the valve of Figure 60 according to an embodiment of the present description;

[00288] Figure 62 shows the valve of Figure 60 attached to the engine and the valve fixing structure of Figure 61 according to an embodiment of the present description;

[00289] Figure 63 shows another motor and valid clamping structure

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78/190 valve for coupling to the valve of Figure 60 according to an embodiment of the present description;

[00290] Figure 64A shows a valve having a collar and several fingers to regulate the flow of fluid through a fluid line according to an embodiment of the present description;

[00291] Figure 64B shows a cross-sectional view of the valve of Figure 64A according to an embodiment of the present description;

[00292] Figure 65 shows a cross-sectional view of a valve having two curved surfaces to position a fluid tube between being to regulate the flow of fluid through the fluid tube according to an embodiment of the present description;

[00293] Figures 66A-66G show several views of a valve that has a button for moving a connecting member which is locked in position after the button is moved according to an embodiment of the present description;

[00294] Figure 67 shows a graph that illustrates the performance vs. flow rates for a valve according to an embodiment of the present description;

[00295] Figure 68A shows a flow meter that uses binary optics according to an embodiment of the present description;

[00296] Figure 68B shows the circuit for use with Figure 68A according to an embodiment of the present description;

[00297] Figures 69A-69I show several views of a safety valve that can be used with a flow meter according to an embodiment of the present description;

[00298] Figure 70 shows a flow chart illustrating a method for estimating the growth of gout and / or flow within a drip chamber according to an embodiment of the present description;

[00299] Figures 71A-71E show images taken by a meter

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79/190 flow with a template superimposed on these to illustrate the method of Figure 70 according to an embodiment of the present description; [00300] Figure 72 shows a set of backlight that can be adjusted according to one embodiment of the present description;

[00301] Figures 73A-73C show several views of a tube restoration apparatus according to an embodiment of the present description;

[00302] Figure 74 shows a system for regulating the flow of fluid using a valve that has two flexible strips according to an embodiment of the present description;

[00303] Figure 75 shows the valve of Figure 74 according to an embodiment of the present description;

[00304] Figure 76A shows a valve that uses a fluid-based bladder according to an embodiment of the present description;

[00305] Figure 76B shows a cross-sectional view of the assembled valve of Figure 76A with two elastomeric fillings according to an embodiment of the present description;

[00306] Figure 77 shows a system to regulate the flow of fluid using a valve that has two flexible strips that can be actuated by a linear actuator according to an embodiment of the present description;

[00307] Figure 78 shows the system of Figure 77 with the valve acted in accordance with an embodiment of the present description;

[00308] Figure 79 shows an enlarged view of the valve of Figures 77-78 according to an embodiment of the present description;

[00309] Figure 80 shows an enlarged view of the valve as operated in Figure 78 according to an embodiment of the present description;

[00310] Figure 81 shows several images for use to illustrate a method for estimating gout growth and / or flow

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80/190 fluid illustrated in Figures 82A-82B according to an embodiment of the present description; and [00311] Figures 82A-82B shows a flowchart illustrating a method for estimating drop growth and / or fluid flow according to an embodiment of the present description;

[00312] Figure 83 shows a flow chart of a method for reducing condensation noise according to an embodiment of the present description;

[00313] Figure 84 shows another valve for use with a flow meter according to an embodiment of the present description;

[00314] Figure 85A shows a perspective view of another valve in an open position according to an embodiment of the present description;

[00315] Figure 85B shows a perspective view of the valve of Figure 85A in a closed position according to an embodiment of the present description;

[00316] Figure 85C shows a view of the valve of Figure 85A with the valve housing and plunger guide removed according to an embodiment of the present description;

[00317] Figure 86 shows a cross-sectional view of the valve housing of Figures 85A-85C and the filling when in a closed position according to an embodiment of the present description;

[00318] Figure 87A shows a front view of an apparatus with the door closed, the apparatus is used to control the flow of fluid through a drip chamber connected to a tube according to an embodiment of the present description;

[00319] Figure 87B shows a perspective view of the apparatus of Figure 87A with the door open, detaching the valve according to an embodiment of the present description;

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81/190 [00320] Figure 87C shows a perspective view of the apparatus of Figure 87A with the door open, highlighting the security cut-out mechanism according to an embodiment of the present description;

[00321] Figure 87D shows a bottom view of the apparatus of Figure 87A according to an embodiment of the present description;

[00322] Figure 88A shows a perspective view of another device used to control the flow of fluid through a drip chamber connected to a tube, in which the device has the door open, according to an embodiment of the present description;

[00323] Figure 88B shows a perspective view of only the valve of Figure 88A according to an embodiment of the present description;

[00324] Figure 88C shows the internal parts of the valve of Figure 88B according to an embodiment of the present description;

[00325] Figure 88D shows a simplified diagram to illustrate the operation of the valve shut-off mechanism in a closed door position according to an embodiment of the present description;

[00326] Figure 88E shows a simplified diagram to illustrate the valve shut-off mechanism in the open door position according to an embodiment of the present description;

[00327] Figures 89A-89B show a flow chart of a method for controlling the flow of fluid through a drip chamber according to an embodiment of the present description;

[00328] Figure 90 shows a diagram of a system for controlling the flow of fluid through a drip chamber; and [00329] Figure 91 shows an apparatus configured to control the flow of fluid through a drip chamber connected to a tube and communicate with an RFID interrogator according to an embodiment of the present description.

[00330] Figure 92 shows an obstructed drip chamber

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82/190 which can make it difficult to obtain an accurate image of the drip chamber by an image sensor.

[00331] Figure 93 shows a flow chart of a method for obtaining an image of a drip chamber.

[00332] Figure 94 shows a graphical representation of drops, as seen by an image sensor, as each drop grows inside a drip chamber and subsequently falls.

[00333] Figure 95 shows a graphical representation of a system for conducting the status of a device.

DETAILED DESCRIPTION [00334] Figure 1 shows a block diagram of a system 1 for regulating fluid flow according to an embodiment of the present description. For example, system 1 can regulate, monitor, and / or control the flow of fluid to a patient 3. System 1 includes a fluid reservoir 2 to infuse the fluid contained therein to patient 3. Fluid reservoir 2 is fed by gravity to a drip chamber 4 through a fluid tube 5. Fluid reservoir 2, drip chamber 4, and patient 3 can be considered as part of system 1 or can be considered as separate workpieces or optional for system 1 (for example, any fluid reservoir 2 and drip chamber 4 can be used to treat any patient 3).

[00335] A flow meter 7 monitors the drip chamber 4 to estimate a flow rate of liquid flowing through the drip chamber 4. The fluid in the drip chamber 4 is fed by gravity to a valve 6. Valve 6 regulates (i.e., varies) fluid flow from fluid reservoir 2 to patient 3 by regulating fluid flow from drip chamber 4 to patient 3. Valve 6 can be any valve as described herein, including a valve that has two curved formed members, a valve that has

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83/190 two flexible plates, a valve that tightens (or evenly compresses) over the pipe over a significant length of the pipe, or the like. Valve 6 can be a reverse Bourdon tube valve that operates in the opposite way to a Bourdon tube in which a fluid path deformation causes changes in the fluid flow instead of the fluid flow causing the fluid path deformation. [00336] In alternative embodiments, system 1 optionally includes an infusion pump 414 (for example, a peristaltic pump, a finger pump, a linear peristaltic pump, a rotary peristaltic pump, a cassette-based pump, a membrane pump , another pump, etc.) coupled to the fluid tube 5. The outlined box designated as 414 represents the optional nature of the 414 infusion pump, for example, the infusion pump may not be used in some embodiments. The infusion pump 414 can use flow meter 7 in return to control the flow of fluid through the fluid tube 5. Infusion pump 414 can be wirelessly communicating with flow meter 7 to receive the flow rate this. The infusion pump 414 can use a return control algorithm (for example, the control component 14 in Figure 1) to adjust the fluid flow, such as a proportional - integral - derivative (PID), bang- bang, neural network, and / or fuzzy logic. In this specific exemplary embodiment (that is, an embodiment that has the infusion pump 414), valve 6 is optional. However, in other embodiments, valve 6 may or may not be used, and / or be optional. The infusion pump 414 can adjust the rotation of a cam and / or motor according to the flow meter 7 measurements, such as flow rate, infused volume, total infused volume, etc. In addition or alternatively, the infusion pump 414 can stop the flow of fluid (for example, stopping the pump action) when the flow meter 7 communicates to the infusion pump 414 that a con-

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84/190 free flow exists. In additional modes, the monitoring client 8 controls the operation of the infusion pump 414 (for example, via a wireless connection) and receives feedback from the flow meter 7.

[00337] In some embodiments, fluid reservoir 2 is pressurized to facilitate fluid flow from fluid reservoir 2 to patient 3, for example, in the case where fluid reservoir 2 (e.g., an IV pouch) is below the patient 3. Pressurization provides sufficient mechanical energy to cause fluid to flow to the patient 3. A variety of pressure sources, such as physical pressure, mechanical pressure, and pneumatic pressure can be applied inside or outside the patient. fluid reservoir 2. In such an embodiment, pressurization can be provided by a rubber band wrapped around the IV pouch.

[00338] Flow meter 7 and valve 6 can form a closed loop system to regulate fluid flow to patient 3. For example, flow meter 7 can receive a target flow rate from a monitoring client 8 by communication using transceivers 9, 10. That is, transceivers 9, 10 can be used for communication between flow meter 7 and the monitoring client 8. Transceivers 9, 10 can communicate with each other using a modulated signal to encode various types of information such as digital data or an analog signal. Some modulation techniques used may include using a carrier frequency with FM modulation, using AM modulation, using digital modulation, using analog modulation, or the like.

[00339] Flow meter 7 estimates flow rate through drip chamber 4 and adjusts valve 6 to achieve the target flow rate received from monitoring client 8. Valve 6 can be controlled by flow meter 7 directly from communication lines

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85/190 coupled to a valve 6 actuator or via a wireless connection of the flow meter 7 to a built-in circuit of valve 6. The built-in electronics of valve 6 can be used to control the performance of valve 6 via a actuator coupled to it. This closed loop mode of flow meter 7 and valve 6 can use any control algorithm including a PID control algorithm, a neural network control algorithm, a fuzzy logic control algorithm, and the like, or some combination thereof .

[00340] The flow meter 7 is coupled to a support member 17 which is coupled to the drip chamber 4 via a coupler 16. The support member 17 also supports a backlight 18. The backlight 18 includes a network of LEDs 20 that provide illumination for the flow meter 7. In some specific embodiments, the backlight 18 includes a background pattern 19. In other embodiments, the backlight 18 does not include the background pattern 19. In some modalities, the bottom pattern 19 is present only in the lower portion of the backlight 18 and there is no bottom pattern 19 at the top (for example, away from the ground) of the backlight 18.

[00341] Flow meter 7 includes an image sensor 11, a free flow detector component 12, a flow rate estimator component 13, a control component 14, an exposure component 29, a processor 15, and a transceiver 9. Flow meter 7 may be battery operated, may be powered by an AC outlet, may include supercapacitors, and may include a built-in power supply circuit (not explicitly shown).

[00342] The image sensor 11 can be a CCD sensor, a CMOS sensor, or another image sensor. Image sensor 11 captures images from the drip chamber 4 and communicates the image data that corresponds to the images captured to the processor

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86/190

15.

[00343] Processor 15 is also coupled to the free flow detector component 12, the flow rate estimator component 13, the control component 14, and the exposure component 29. The free flow detector component 12, the flow rate estimator component 13, the control component 14, and the exposure component 29 can be implemented as executable instructions per processor that are executable by processor 15 and can be stored in memory, such as processor readable memory , non-transitory, ROM, RAM, EEPROM, a hard drive, a hard drive, an instantaneous drive, and the like.

[00344] Processor 15 can execute the instructions of the free flow detector component 12 to determine if a free flow condition exists within the drip chamber 4 by analyzing the image data from the image sensor 11. Various modalities of the detector component free flow 12 to detect a free flow condition are described below. In response to a detected free flow condition, processor 15 can make a function call to control component 14 to send a signal to valve 6 to completely stop the flow of fluid to patient 3. That is, if the free flow detector component 12 determines that a free flow condition exists, flow meter 7 can instruct valve 6 to stop the flow of fluid, can instruct monitoring client 8 to stop the flow of fluid (which can communicate with valve 6 or pump 414), and / or can instruct pump 414 to stop pumping or occlude the flow of fluid using the internal safety occluder.

[00345] The flow rate estimator component 13 estimates the flow rate of fluid flowing through the drip chamber 4 using the image data from the image sensor 11. The process

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87/190 dor 15 communicates the estimated flow rate for the control component 14 (for example, via a function call). Several ways of estimating the flow rate are described below. If the flow rate estimator component 13 determines that the flow rate is greater than a predetermined limit or is outside a predetermined range, flow meter 7 can instruct valve 6 to stop the flow of fluid (which can communicate with valve 6 or pump 414), can instruct monitoring client 8 to stop the flow of fluid (which can communicate with valve 6 or pump 414), and / or can instruct pump 414 to stop pump or occlude the fluid flow using an internal safety occlusion.

[00346] Processor 15 controls the network of LEDs 20 to provide enough light for the image sensor 11. For example, Exposure component 29 can be used by processor 15 or in conjunction with it to control the network of LEDs 20 from so that image sensor 11 captures sufficient image data for use by the free flow detector component 12 and the flow rate estimator component 13. Processor 15 can implement an exposure algorithm stored by exposure component 29 (see Figure 2) to control the lighting conditions and / or the exposure of the image sensor 11 when generating the image data. In addition or alternatively, the display component 29 can be implemented as a circuit, an integrated circuit, a CPLD, a PAL, a PLD, an implementation based on hardware description language, and / or a software system.

[00347] Control component 14 calculates adjustments to be made on valve 6 according to the estimated flow rate of flow rate estimator component 13. For example, and as previously mentioned, control component 14 can implement a PID control algorithm to adjust valve 6 to achieve the rate

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88/190 target flow.

[00348] The monitoring client 8, in some modalities, monitors the operation of system 1. For example, when a free flow condition is detected by the free flow detector component 12, the monitoring client 8 can communicate wirelessly a signal to valve 6 to stop the flow of fluid to patient 3.

[00349] Flow meter 7 may furthermore include several input / output devices to facilitate patient safety, such as several scanners, and may use transceiver 9 to communicate with electronic medical records, drug error reduction system and / or installation services, such as inventory control systems.

[00350] In a specific exemplary embodiment, the flow meter 7 has a scanner, such as an RFID interrogator that interrogates an RFID tag attached to the fluid reservoir 2 or a bar code scanner that scans a reservoir bar code fluid 2. The scanner can be used to determine if the correct fluid is inside the fluid reservoir 2, this is the correct fluid reservoir 2, the treatment programmed in the flow meter 7 corresponds to the fluid inside the fluid reservoir 2 and / or fluid reservoir 2 and flow meter 7 are correct for the specific patient (for example, as determined from a patient's barcode, a patient's RFID tag, or other patient identification).

[00351] For example, flow meter 7 can scan the RFID tag of fluid reservoir 2 to determine whether a serial number or type of fluid encoded within the RFID tag is the same as indicated by the programmed treatment stored in the meter flow meter 7. In addition or alternatively, flow meter 7 for interrogating the fluid reservoir RFID tag 2 for a

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89/190 patient serial number and RFID tag 3 for a patient serial number, and also interrogate electronic medical records using transceiver 9 to determine whether the serial number of fluid reservoir 2 within the patient RFID attached to the fluid reservoir 2 matches the patient's serial number inside the RFID tag attached to patient 3 as indicated by electronic medical records.

[00352] In addition or alternatively, monitoring client 8 can scan the RFID tag of fluid reservoir 2 and the RFID tag of patient 3 to determine that this is the correct fluid within fluid reservoir 2, this is the correct fluid reservoir 2, the treatment programmed in flow meter 7 corresponds to the fluid within fluid reservoir 2, and / or fluid reservoir 2 is correct for the specific patient (for example, as determined from a patient barcode) patient, RFID tag, electronic medical records, or other patient identification or information). In addition or alternatively, the monitoring client 8 or the flow meter 7 can query the database of electronic medical records and / or the pharmacy to verify the prescription or to download the prescription, for example, using the serial number the barcode on the fluid reservoir 2 or the RFID tag attached to the fluid reservoir 2.

[00353] Figure 2 shows a flow chart of a method 21 for exposing an image sensor, for example, image sensor 11 of Figure 1, according to an embodiment of the present description. Method 21 includes acts 22, 23, 24, and 25. Method 21 can be implemented by processor 15 in Figure 1 (for example, as exposure component 29) and can be implemented as a method implemented by processor, as a set of instructions configured for execution by one or more processors, in

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90/190 hardware, in software, and the like, or some combination thereof. [00354] Act 22 selects a region of interest. For example, referring again to Figure 1, image sensor 11 includes a field of view that includes a drip chamber 4. However, drip chamber 4 may not occupy the entire field of view of image sensor 11. O act 22 selects only the pixels of the image sensor 11 that show, for example, the drip chamber 4.

[00355] Act 23 determines whether a pixel is within the region of interest 23. If the pixel in Act 23 is a pixel that forms the image, for example, drip chamber 4, then Act 23 determines that it is within the region of interest. Likewise, in this example, if the pixel in Act 23 is one that does not image the drip chamber 4, Act 23 determines that the pixel is not within the region of interest.

[00356] Act 24 activates a backlight, for example, the backlight 18 of Figure 1, if the pixel is within the region of interest. The pixels of an image sensor can be exposed for different times. Thus, the backlight 18 can be activated only when the pixels within the region of interest are being exposed. For example, some image sensors include vertical and horizontal synchronization signals. The backlight can be synchronized with these signals to turn on when a pixel of interest is being exposed.

[00357] In some embodiments of the present description, a subset of the LEDs of the backlight (for example, a subset of the LED network 20, which can be a two-dimensional network) can be connected. The subset may be a subset sufficient to sufficiently illuminate the pixel being exposed if the pixel is within the region of interest.

[00358] Act 25 exposes the pixel. If in Act 23 it was determined that the

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91/190 pixel is within the region of interest, the pixel will be exposed with at least a portion of the backlight turned on in act 25. In addition, if in act 23 it was determined that the pixel is not within the region of interest, the pixel will be exposed without at least a portion of the backlight turned on in act 25.

[00359] Figure 3 shows a time diagram 29 illustrating an embodiment of the method of Figure 2 according to an embodiment of the present description. Time diagram 29 includes strokes 26, 27, and 28. Trace 26 is a vertical sync signal from an image sensor and trace 27 is a horizontal sync signal from the image sensor (for example, the image sensor 11 of Figure 1). A circuit or software routine (for example, exposure component 29 found in flow meter 7 in Figure 1) can use synchronization strokes 26, 27 to generate a backlight enable signal 28 that is used to activate a backlight or a subset thereof.

[00360] Figures 4A-4B show illustrations of image data from a flow meter 7 that illustrate an embodiment of the method of Figure 2 according to the time diagram of Figure 3 according to an embodiment of the present description. Figure 4A illustrates the image data taken by a flow meter, such as flow meter 7 in Figure 1, without using the exposure algorithm illustrated in Figures 2 and 3; Figure 4B illustrates the image data taken by the flow meter using the exposure algorithm illustrated in Figures 2 and 3. Less energy is needed to provide lighting during the capture of the image in Figure 4B than to provide lighting for the capture of the image in Figure 4A due to the lower use of backlight.

[00361] Figure 5 shows a diagram of a flow meter 67 and a valve 71 that are integrated together for coupling to a chamber

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92/190 drip tray 409 and an IV bag 69 according to an embodiment of the present description. The flow meter 67 includes an optical drip counter 68 that receives fluid from the IV pouch 69. The optical drip counter 68 can be an image sensor, a pair of image sensors, a capacitive drip counter, and / or the like . Flow meter 67 is coupled to a tube 70 coupled to a roller clamp 71 which is controlled by a motor 72. Motor 72 is coupled to a lead screw mechanism 73 to control a roller clamp 71 through interaction with interaction members 74.

[00362] Motor 72 can be a servo motor and can be used to adjust the flow rate through tube 70. That is, flow meter 67 can also function as a flow meter and regulator. For example, a processor 75 within flow meter 67 can adjust motor 72 so that a desired flow rate is achieved as measured by the optical drip counter 68. Processor 75 can implement a control algorithm using the drip counter optical 68 as a return, for example, a PID control loop with the output supplied to the motor 72 and the return received from the optical drip counter 68.

[00363] In alternative modalities, the motor 72, the lead screw mechanism 73, and the roller clamp 71 can be replaced and / or supplemented by an actuator that squeezes the tube 70 (for example, using a cam mechanism or articulation driven by a motor) or these can be replaced by any sufficient roller, screw, or slide driven by a motor. For example, in some embodiments of the present description, roller clamp 71 can be replaced by any valve as described herein, including a valve that has two C-shaped members, a valve that has two curved support members, a valve that

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93/190 has two flexible plates, a valve that tightens on the pipe over a significant length of the pipe, or the like.

[00364] The flow meter 67 can also optionally include a display. The display can be used to adjust the target flow rate, display the current flow rate, and / or provide a button, for example, a touch screen button to stop the flow rate.

[00365] Figure 6 is a block diagram of an image formation system 78 of a flow meter to form an image of a drip chamber according to an embodiment of the present description. The imaging system 78 as shown in Figure 6 can be used within any flow meter described herein, including flow meter 7 in Figure 1 and / or flow meter 67 in Figure 5.

[00366] The image formation system 78 of Figure 6 includes an image sensor 63, a uniform backlight 79 to shine the light at least partially through the drip chamber 59, and an infrared (IR) filter 80 that receives the light from the uniform backlight 79.

[00367] System 78 also includes a processor 90 that can be operatively coupled to image sensor 63 and / or uniform backlight 79. Processor 90 implements an algorithm to determine when a free flow condition exists and / or to estimate a flow rate (for example, using the free flow detector component 12 or the flow rate estimator component 13 of Figure 1). Processor 90 may be in operative communication with processor-readable memory 91 (e.g., processor-readable, non-transient memory) to receive one or more instructions to implement the algorithm to determine whether a free flow condition exists and / or estimate the flow rate. The one or more instructions of the processor readable memory 91 are configured

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94/190 radas for execution by the processor 90.

[00368] The uniform backlight 79 can be a network of light emitting diodes (LEDs) that have the same or different colors, a light bulb, a window to receive ambient light, an incandescent light, and the like. In some embodiments, the uniform backlight 79 may include one or more point source lights.

[00369] Processor 90 can modulate uniform backlight 79 according to image sensor 63. For example, processor 90 can activate uniform backlight 79 for a predetermined amount of time and signal image sensor 63 to capture at least one image, and then signal the uniform backlight 79 to turn off. The one or more images from the image sensor 63 can be processed by the processor 90 to estimate the flow rate and / or detect free flow conditions. For example, in an embodiment of the present description, the system 78 monitors the size of the drops being formed inside the drip chamber 59, and counts the number of drops that flow through the drip chamber 59 within a predetermined amount of time; the processor 90 can average the periodic flow of the individual drops over a period of time to estimate the flow rate. For example, if X drops each having a volume Y flow through the drip chamber at a time Z, the flow rate can be calculated as (X * Y) / Z.

[00370] In addition or alternatively, system 78 can determine when fluid IV is flowing through drip chamber 59 (i.e., during a free flow condition). The uniform backlight 79 shines light through the drip chamber 59 to provide sufficient illumination for the image sensor 63 to form the image of the drip chamber 59. The image sensor 63 can capture one or more images of the drip chamber 59 .

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95/190 [00371] Other system orientations and configurations 78 can be used to take into account the orientation and uniform backlight output characteristics 79, the sensitivity and orientation of the image sensor 63, and the ambient light conditions. In some embodiments of the present description, processor 90 implements an algorithm that uses uniformity of images collected by image sensor 63. Uniformity can be facilitated by uniform backlight 79. For example, consistent uniform images can be captured by the image sensor image 63 when a uniform backlight 79 is used.

[00372] Ambient lighting can cause inconsistencies in the images received from the image sensor 63; for example, direct sunlight provides inconsistent lighting because the sun can be intermittently obscured by clouds and the brightness of the sun and the angle of illumination depend on the time of day. Therefore, in some embodiments of the present description, an IR 80 filter is optionally used to filter part of the ambient light to mitigate variations in the images captured by the image sensor 63. The IR 80 filter can be a narrowband infrared light filter placed in front of the image sensor 63; and the uniform backlight 79 can emit a light that is approximately the same wavelength as the center frequency of the filter band 80. The IR filter 80 and the uniform backlight 79 can have a center frequency of approximately 850 nanometers. In some embodiments, the imaging system 78 may be surrounded by a visually translucent but IR-blocking envelope. In alternative modalities, other optical frequencies, bandwidths, central frequencies, or filter types can be used in the system 78.

[00373] In some embodiments, processor 90 can use

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96/190 a template to perform a puddle template matching within the drip chamber 59. Any preprocessing can be performed before the template matching operation. In addition, if camera 63 is arranged higher than a preferred position, a mirror can be used so that the view of camera 63 is of a preferable view of drip chamber 59. The position of the peak template match can correlated with the position of the puddle and with it the volume of the puddle.

[00374] If the pool is too low, the device can trigger a safety valve (described below) because the water is leaving the pool and draining towards the patient at an unsafe rate. The backlight 79 can be on or off, depending on the mode. Oscillations at the top of the pool can be monitored to determine the frequency of water resonance. The resonance of the top of the pool as the drops reach the pool may be correlated with the volume of the pool. In other embodiments, the sudden change in the pool can be correlated with a drop hitting the pool so that the processor 90 can count the number of drops per unit time and estimate the flow of fluid through them.

[00375] In some modalities, an autofocus can be used to find the water line. That is, a focal line can be focused to ensure that the entire image is in focus.

[00376] In some embodiments, processor 90 may be coupled to a wire recorded on a PCB board making it a software radio. This allows the processor 90 to communicate the information to another device capable of operating at sufficient frequencies.

[00377] Figure 7 is a graphic illustration of an image 81 captured by image sensor 63 of system 78 of Figure 6 according to

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97/190 with an embodiment of the present description. Image 81 is an image of a drip chamber 59 having condensation 82 and flow 83 caused by a free flow condition therein. An edge detection can be used to determine the position of flow 83 and / or condensation 82, in some embodiments. In addition or alternatively, a background or pattern image can be used.

[00378] Figure 8 is a block diagram of an image formation system 84 of a flow meter to image a drip chamber according to an embodiment of the present description. The imaging system 84 can be used with any flow meter described herein, including flow meter 7 in Figure 1 and flow meter 67 in Figure 5.

[00379] System 84 includes a network of lines 85 that are opaque behind drip chamber 59. System 84 uses network of lines 85 to detect a free flow condition. The free flow detection algorithm (for example, the free flow detector component 12 of Figure 1) can use the presence or absence of drops to determine whether a flow condition (for example, a free flow condition) exists or do not.

[00380] In specific modalities, lines 85 are only present in a fraction of the image (for example, the background pattern only occupies a fraction of the backlight 18 or the binary optics only causes the pattern to appear in a fraction of the image, such as the bottom or top half). For example, a lower fraction of the image may include a strip pattern.

[00381] Referring now to Figure 9, a graphic illustration of an image 86 is shown as captured by image sensor 63 of Figure 8 when a free flow condition exists within the drip chamber 59 according to one embodiment of the present

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98/190 description. Fig. 86 illustrates the condition in which the drip chamber 59 experiences a free flow condition and illustrates the effect that fluid flow 87 acts as a positive cylindrical lens. That is, as shown in Figure 9, the line network 85 as captured in an image by the image sensor 63 is shown as an inverted line pattern 88 of the line network 85 compared to a non-free flowing condition. The appearance of the inverted line pattern 88 is caused by changes in light when light passes through the fluid flow 87 as the light approaches the image sensor 63.

[00382] In some embodiments of the present description, light illumination having an optical wavelength of approximately 850 nanometers can be used to create the image 86. Some materials may be opaque in the visible spectrum and transparent in the near IR spectrum in approximately 850 nanometers and therefore can be used to create the 85 line network. The 85 line network can be created using various rapid prototyping plastics. For example, the network of lines 85 can be created using a rapid prototype structure printed with an ink opaque to the infrared or coated with a metal to make the network of lines 85. In addition or alternatively, in some embodiments of the present description, another method for creating the network of lines 85 is to create a circuit board with the lines deposited in copper. In another embodiment, the line network 85 is created by placing a ribbon cable over the uniform backlight 79; the wires of the ribbon cable are opaque to the infrared spectrum, but the insulation is transparent so that the spacing of the wires can form the line for use during image formation by the image sensor 63 (see Figure 8). In additional embodiments, a piece of thin EDMed metal can be used. The metal is opaque to light and the spaces between deposits 870170016724, of 03/14/2017, p. 105/347

99/190 metal material sites can be very finely controlled during manufacture to allow IR light to pass through spaces.

[00383] Processor 90 implements an algorithm to determine when a free flow condition exists (for example, using the free flow detector component 12 of Figure 1). Processor 90 may be in operative communication with processor-readable memory 91 (e.g., processor-readable, non-transient memory) to receive one or more instructions to implement the algorithm to determine whether a free flow condition exists. The one or more instructions from processor readable memory 91 are configured to execute by processor 90.

[00384] Referring again to Figure 8, blood can be used by system 84. For example, system 84 can determine when a free blood flow condition exists when using image sensor 63, IR filter 80, and light uniform background 79 configured, for example, for use using an optical light that has a wavelength of 850 nanometers or 780 nanometers, for example, when using bovine blood. The blood may appear opaque compared to the image made using water.

[00385] The following algorithm implemented by processor 90 and received from processor readable memory 91 can be used to determine when a free flow condition exists: (1) establish a background image 89 (see Figure 10); and (2) subtracting the background image 89 from the current image. In addition, processing can be performed on the resulting image.

[00386] In some embodiments of the present description, the background image 89 of Figure 10 can be dynamically generated by processor 90. The dynamic background image can be used to take into account changing conditions, for example. condensation or res

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100/190 drops 82 on the surface of the drip chamber 59 (see Figure 7). For example, in a specific mode, for each new image captured by the image sensor (for example, 63 in Figure 8), the background image has each pixel multiplied by 0.96 and the current image (for example, the most recently captured) has a respective pixel multiplied by 0.04, after which the two values are added together to create a new value for a new background image for that respective pixel; this process can be repeated for all pixels. In yet another example, in a specific modality, if a pixel of the new image is in a row, x, and in a column, y, the new background image in the row, x, and column, y, is the image value. previous background in the row, x, and column, y, multiplied by 0.96, which is added to the pixel value in the row, x, and column, y of the new image multiplied by 0.04.

[00387] When the system 84 has no water flowing through the drip chamber 59 (see Figure 8) the resulting subtraction can be almost completely black, that is, low pixel magnitudes, thereby facilitating the algorithm to determine that the chamber drip 59 has no water flowing through it.

[00388] Figure 11 shows an image 92 of the image sensor 63 when there is a drop inside the drip chamber 59 (see Figure 8). Figure 12 shows a background image 93 used by system 84. When system 84 has a drop as shown in image 92 in Figure 11, system 84 in Figure 8 has few high contrast points where the image of the line network is distorted through the droplet lenses as illustrated by an image 94 in Figure 13. Image 94 in Figure 13 is generated by taking, for each respective pixel, the absolute value of the subtraction of image 92 in Figure 11 from image 93 in Figure 12, and converting each respective pixel to a white pixel if the value is above a predetermined limit or

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101/190 otherwise converting p pixel to a black pixel when the value is below the predetermined limit. Each white pixel within image 94 of Figure 13 is a result of a difference in the location of that pixel between images 92 and 93 that is greater than a predetermined limit.

[00389] For example, consider three respective pixels in Figures 11, 12, and 13 that have a location of row x and column y. To determine the pixel of row x and column y for image 94 in Figure 13, the pixel in row x and column y of image 92 in Figure 11 is subtracted from the pixel in row x and column y of image 93 in Figure 12, then the absolute value the result of the subtraction is taken; and if the absolute value of the result is above a predetermined limit (for example, above a gray scale value of 128, for example,), the pixel at the location of row x and column y of image 94 in Figure 13 is white , otherwise the pixel at the location of row x and column y of image 94 in Figure 13 is black.

[00390] When it is determined that few high contrast points exist within image 94 of Figure 13, processor 90 of system 84 (see Figure 8) determines that drops are being formed inside the drip chamber 59 and no flow condition free exists. The droplet images can be used to determine the size of the droplets to estimate a flow rate as described herein.

[00391] Figure 14 is a graphical representation of part of the image processing that can be performed using Figures 11-13 to determine whether a free flow condition exists according to a modality of the present description. Referring to Figures 14 and 13, all white pixels for each line are added together, and are shown in Figure 14 as results 183. The y-axis represents the line number, and the x-axis represents the

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102/190 added number of white pixels for each respective line.

[00392] Referring now only to Figure 14, as previously mentioned, the number of white pixels for each line is added together and is illustrated as results 183, which are used to determine whether or when a free flow condition exists. In some specific embodiments, processor 90 of system 84 (see Figure 8) determines that a free flow condition exists when a predetermined number of contiguous values of the summed lines of the results 183 exists above a limit 184. For example, within the results 183, a range of a plurality of contiguous lines represented generally by 185 has a total value above the 184 limit. When greater than a predetermined number of contiguous added lines is determined to exist within the results 183 above a predetermined limit (for example, limit 184), a free flow condition is determined to exist by processor 90 of Figure 8. For example, as shown in Figure 14, the range of the plurality of contiguous summed lines 185 is below the predetermined number of contiguous summed lines (i.e., the 185 is not wide enough) and therefore a free flow condition is determined not to exist.

[00393] Figure 15 shows an image 95 showing a flow as captured by image sensor 63 of Figure 8 when a free flow condition exists. Figure 16 shows a background image 96. Figure 17 shows an image 97 formed by the absolute value of the difference between image 96 in Figure 16 and image 95 in Figure 15 when the absolute value is converted or to a white pixel (when the absolute value of the difference is above a limit) or for a black pixel (when the absolute value of the difference is below). As shown in Figure 17, high contrast points caused by the reverse orientation of lines in the flow that runs from top to bottom are detectable by processor 90. Processor 90 in Figure 8

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103/190 can use image 97 to determine if a free flow condition exists using the algorithm described above.

[00394] That is, as shown in Figure 18, results 186 are shown as having a contiguous range 187 of results 186 that are above a limit 188. As the contiguous range 187 of added lines is greater than a limit number predetermined contiguous values above limit 188, a free flow condition is determined to exist by processor 90 (see Figure 8). That is, the contiguous range of results 186 above limit 188 is greater than a predetermined limit range of contiguous values; therefore, processor 90 determines that a free flow condition exists when using results 186 of Figure 18.

[00395] In yet an additional modality of the present description, the intensity, the squared intensity, or another function can be used to produce the results 183 of Figure 14 and / or the results 186 of Figure 18. In still an additional mode, one or more data smoothing functions can be used to smooth the results 183 and / or 186, such as a spline function, a cubic spline function, a B spline function, a Bezier spline function, a polynomial interpolation, a moving average, or other data standardization function.

[00396] For example, an image from image sensor 63 in Figure 8, for example, image 95 in Figure 15, can be subtracted from a background image, for example, image 96 from Figure 16, to obtain values of intensity. That is, a pixel of line x and column y of Figure 15 can be subtracted from a pixel of line x and column y of image 96 of Figure 16 to create an intensity value on line x and column y; this can be repeated for all pixel locations to obtain all intensity values. The intensity values for each line can be added together to obtain the results 183

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104/190 and / or 186 (see Figures 14 and 18, respectively), so that processor 90 can determine that a free flow condition exists when the lines added to the intensity values have a contiguous range of lines added above one limit. In some modalities, the intensity values are converted to absolute values of the intensity values, and the lines added to the absolute values of the intensity values are used to determine whether a contiguous range of lines added to the absolute values is above a limit range of contiguous values. In addition or alternatively, the intensity can be squared and then the processor 90 can add the squared intensity lines and determine whether a contiguous range of lines plus the squared intensity values exists in addition to a limit range of contiguous values for determine if a free flow condition exists.

[00397] In some embodiments, a predetermined range of contiguous values above a limit (for example, min and max ranges) of the lines added together with intensity values or intensity squared values can be used by processor 90 to determine whether a drop of liquid is inside the image. For example, each line of the intensity value lines (or the squared intensity values) can be added together and a range of the added values can be above a limit number; if the range of contiguous values is between a minimum range and a maximum range, processor 90 can determine that the range of contiguous values above a predetermined limit is one drop within the field of view of the image sensor 63 (see Figure 8 ). In some embodiments of the present description, the lines added together with intensity values or intensity squared values can be normalized, for example, normalized to have a value between 0 and 1.

[00398] The following describes a uniform function similar to

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105/190 cubic spline (ie, the cubic spline type function) that can be used on the summed lines, the summed lines of intensity values of, or the summed lines of intensity values squared before determination by the processor 90 for determine if a free flow condition exists. In some specific embodiments, the cubic spline function can be used to identify blocks, as described below, which can facilitate the identification of the processor 90 of free flow conditions.

[00399] The cubic spline function is analogous to the cubic spline, but this unifies a data set instead of faithfully imitating a given function. Having data sampled in the interval ^{[o, 1]} (for example, the sum along a line of squared intensity or intensity that is normalized) processor 90 (see Figures 6 or 8) can find the best adjusted set of cubic functions in the intervals [ ^x o> ^X 1]> [ ^X 1> ^X 2] ^[X N -1, ^X N] with ^{Xo 0} and ^{Xn 1} where the total function is continuous with continuous derivatives and continuous curvature. [00400] The definition of standard cubic spline is illustrated in Equation (1) as follows:

c ( ^x ) = 4 ( ^x ) y ⁺ B. ( ^x ) y _{l +} 1 ⁺ C. ( ^x ) y + D. ( ^x ) y ^ ^x i ^{£ X £ X.} + 1 ( ₁ ), [00401] with the Equations (2) functions:

^4, B. ^, C. ^, D. defined as in the set of

x. + 1 - x x. + 1 -x

A. (x) = —-- ~, ^X. + 1 ^{- x A} _A 2

C. ^(x (Af ^{(x) -4 (x)} ), x - x.

x - Xi

B = D ^X. + 1 ^{- x} . ^A.

A ²

D = ~ t (Bi (x) - B. (x)) ₍₂₎ [00402] Equations (1) and (2) guarantee continuity and continuity of curvature. The only values that can be freely // chosen are y, ^yo and ^yN . Please note that Equation (3) is chosen as follows:

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106/190 // // _η '' = ^y = ⁰ (3), // [00403] that is, the function is flat at 0 and 1. The remaining ^y must satisfy the following set of Equations (4):

y ^- yo Do , yíDo _ y2 ^- y yDDx 3 ^y 2D1 6 3 D1 y2 ^- y , y1D1 , y ^ 1 y3 ^- y2 _- ^y 2 ^Δ 2 _- ^y 3 ^Δ 2 D1 ¹ 6 3 ^Δ 2 3 6 ya ^- y2 1 ^and 2D2 1 ^and 3D2 y4 ^- y3 _- ^y 3 ^Δ 3 y4D3 D2 ¹ 6 ^{1 1} 3 D3 3 6

^y N-2 ^and N-3 »A l ^and N-3DN-3 »A l ^and N-2DN-3 ^y N-1 ^and N-2 »A ^and N-2D N-2 »A ^y N-1D N-2 D N-3 ¹ 6 ¹ 3 D N-2 3 6

_ Λ Λ _ ”Λ ^y N-1 ^-y N-2 i ^y N-2DN-2 i ^y N-1DN-2 ^y N ^-y N-1 __ ^y N-1DN-1

DN-2 ^{6 3} DN-1 ³ (04).

[00404] The set of Equations (4) can be rewritten as the set of Equations (5) as follows:

D0 ⁺ d1

From D

Δ ₁ //, D, + Δ ₂ v, Δ ₂ »y ₁

-2 y1 y -2 y_f ^-

Δ ₂ v, Δ ₂ + d ₃ η, Δ ₃ »y ₂ ~ 2 ^V : '- ^y 3 ⁺ ~ 2Λ_ <

JL ₊

Dl Δ ^{J y} 2 ⁺ Δ?

JL ₊ JL _{y +} j £, D ^ Δ3 J ^y 3 Δ3

DN-4 DN-3 ⁺ DN-2 y i dn-2  yN-3 1 1 ^y N-2 i ^y N-1 6 In-3 3 ^y N-2 ¹ 6 ^y N-1 DN-3 _ D N-3 DN-2 _ DN-2 yN - i DN-2 ^{+ Δ} N-1 ^y N-2 1 ^y N -1 ^{i y} N 2 ¹ 3 ^y N-1 DN-2 _ DN-2 ¹ J DN-1 J DN-1 (5)

[00405] This in turn becomes the Matrix Equation (6):

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107/190

D0 ⁺ D1 D1 0 0 0 0 C η Ί 3 6 y1 D1 6 ^D 1 ^{+ D} 2 3 D2. 6 ’ 0 0 0 ^y 2 0 D2 D2 ⁺ D3 0 0 0 ^y 3 6 3 < 0 0 0 DN-4 ⁺ DN-3 DN -3 0 // ^y N -3 3 6 0 0 0 · DN -3 DN -3 ⁺ DN -2 DN -2 // ^y N -2 6 3 6 0 0 0 0 DN -2 DN -2 ⁺ DN-1 ^y N-1 6 3 _

D0 _j___1_

D0 D1 _L

D1

D1

J___1_

D1 D2

D2

DN -3 j___1_

DN-3 DN-2

DN-2

DN -2

1___1 ^D N-2 ^D N-1

DN-1 y0 y2 ys · I ^y N-3 ^y N-2 ^y N -1. ^y N (6) [00406] The Matrix Equation (6) can be rewritten as the set of Equations (7) as follows:

Fy _dd = ^G yy _dd = ^F-1 Gy = Hy ( ₇ ).

[00407] Choosing the values in vector y using a criterion of least squares on the chosen data is shown in Equation (8) as follows:

^E = Σ |> - AX) y. - B (Xk) y „+1 - c„ (X.) y '- D (X.) y'] ² ₍₈₎ .

[00408] Equation (8) is the minimum deviation between the data and the spline, that is, Equation (8) is an error function. The y-values are chosen to minimize the error as defined in Equation (8). The vector of predicted values can be written as illustrated in Equation (9) as follows:

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108/190 ^y = (Τ ' ^B w) ^y ' ^C w ^{+ D 1 y} dd = ( ^A n; ^{+ B} {S}) ^{y +} ( ^C n; ^{+ D} {/ <}) ^Hy = ^A {£} ^{+ B} {£} ^{+ C} {fc} ^{H + D} _W ^{H y} = Ay (9).

[00409] The elements of the matrix in parentheses of Equation (9) depend on the value x that corresponds to each data point (but this is a fixed matrix). Thus, the final equation can be determined using the pseudo-inverse. In turn, the pseudo-inverse only depends on the x locations of the data set and the locations where the breaks in the cubic spline are adjusted. The implication of this is that once the spline geometry and image size are selected, the best choice for y given a set of measured values y _m is illustrated in Equation (10) as follows:

(A ^T A) ¹ A y [00410] The cubic spline through the square function of the summation intensity of the image will then be given by Equation (11) as follows:

y _cs = A y

Jcs already (11).

[00411] As the maximum values of the cubic spline are of interest, the derivative of the cubic spline is determined and used to determine the maximum values of the cubic spline. The cubic spline derivative is given by Equation (12) as follows:

[00412] Equation (12) can be written as Equation (13) as follows:

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109/190 y :, = ( ^A [») + B; _t) ) y + (c; _t) + Dj _t) ) y _dd = ' ^a í.) + ^B ' ^c ' ^h + D ;,) h] y = ^Ay (13).

[00413] Once the current values of y are found, the cubic spline, y _cs , and its derivative, y ' _cs , can be calculated. Cubic spline data can include blocks of data that include values above a predetermined limit. A tube block is formed by the liquid flowing out of the tube into the drip chamber 59 and a puddle block is formed as the liquid accumulates at the gravity end of the drip chamber 59 (see Figure 8).

[00414] The following algorithm can be applied to the cubic spline data: (1) determine the local maximum of the cubic spline data using the derived information; (2) determine the block surrounding each local maximum location including all points where the cubic spline value is above a limit value; (3) merge all the blocks that intersect; (4) calculate the information about the data block including the center of mass (intensity), the second moment of mass (intensity), the lowest x value of the block, the highest x value of the block, the average sum value original intensity data squared in the block, the standard deviation of the original sum of intensity data squared in the block, and the average intensity of a high-filtered image set in the block; and (5) interpret the collected data to obtain information about when the drops occur and when the system is in flux.

[00415] The average intensity of a high pass filtered image set in the block is used to determine whether the block created by each contiguous strip of spline data is a result of a high frequency artifact (for example, a drop) or a bai artifact

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110/190 x the frequency. This will act as a second background filter which tends to remove artifacts such as condensation from the image. That is, all previous images in an image memory store (for example, 30 previous frames, for example) are used to determine whether the data is a result of high-frequency movement between frames. If the block is a result of low frequency changes, the block is removed, or if this is a result of high frequency changes, the block is kept for further analysis. A finite impulse response filter or an infinite impulse response filter can be used.

[00416] Each block is raised over its physical extension with the height equal to the average value of the data within the block. If a block has an average value of the filtered high-pass image less than the limit, this is an indication that it has been present in several images and must therefore be removed.

[00417] The free flow conditions can be determined by the processor 90 (see Figures 6 or 8) existing using the blocks when the tube block extends almost to the puddle block, the tube block and the puddle block merge together, and / or the summed width range of the puddle and tube blocks (or all blocks) is greater than a predetermined limit, for example, the total length of the blocks exceeds 380 pixels in width. Processor 90 can detect a drop when the transition from the wider to the smaller width block of tube occurs as a result of a drop formation inside the tube and as the drop leaves the tube (i.e., tube) opening of the drip chamber 59. Processor 90 can detect this by looking at the ratio of the current tube block width to the tube block width of previous images, for example, an image where the ratio is less than 0.9 as it is also a local minimum as considered by processor 90 to be an ime formed image

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111/190 diatly after a drop has formed.

[00418] Several filtering algorithms can be used to detect condensation or other low frequency artifacts such as: if a block has a low average value in the filtered high-pass image, then this can be condensation. This artifact can be removed from consideration. In addition or alternatively, long blocks (for example, greater than a predetermined limit) with a low average high pass value are possibly flows because the flow images tend to remain unchanged; processor 90 can determine that long blocks larger than a predetermined threshold correspond to a flow condition. In addition or alternatively, an algorithm can be used on the current image to detect free flow conditions.

[00419] Processor 90 may, in some specific embodiments, use block data to count drops to use system 84 as a drop counter. Processor 90 can also use the width changes in the puddle block as a drop disturbs the water to determine if a bubble formed when the drop hit the puddle. For example, processor 90 can determine that the blocks that form below the puddle block are of bubbles that formed when the drop hit the water. The bubble can be filtered by processor 90 when determining whether a predetermined value of total block ranges indicates that a free flow condition exists.

[00420] In some embodiments of the present description, the depth of field of the system 84 may have a narrow depth of field to make the system 84 less sensitive to condensation and droplets on the chamber walls. In some embodiments, a close focus system can be used.

[00421] Referring now to Figure 19 in another embodiment of the present description, a gauge 189 is used to determine whether a

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112/190 free flow condition exists. Template 189 is used by processor 90 in Figure 8 to determine a pattern match score of 190 when running a template match algorithm on an image, for example, image 94 in Figure 13. For example, template 189 can be compared to image 94 to determine whether a portion or all of image 94 closely matches template 189. As previously mentioned, image 94 in Figure 13 is a difference between a background image and an image captured by image sensor 63 of Figure 8 that has each pixel converted to a black pixel if the difference value for that pixel is below a limit value or a white pixel the difference value for that pixel is above a limit value. All pixels in image 94 will be either a white pixel or a black pixel. If the pattern match score of 190 is above a predetermined threshold, a free flow condition is determined to exist. The template matching method can use a template matching algorithm as found in the Open Source Computer Vision (“OpenCV”) library. For example, template 189 can be used with the OpenCV library's matchTemplate () function call using the CV_TM_CCOEFF method or the CV_TM_CCOEFF_NORMED method. The CV_TM_CCOEFF method uses the pattern matching algorithm illustrated in Equation (14) as follows:

R (x, -y) = ^ JT '(x', y ') - I' (x + x ', y + y')) * ', y' (14), where:

T '(x', y ') - T (x', y ') - 1 / (w Kb Σχ ^ „T (x, y)

I '(x + x', y + y ') = I (x + x', y + y ') - l / fw-h] · Σχ ^ I (x + x, y + y) ( ₁₅ ) [ 00422] Ο I denotes the image, T denotes the template, and R denotes the results. The sum is done over the template and / or the image piece, so that: x '= o ... wl and y' = o ... h- \.

[00423] The R results can be used to determine

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113/190 when template T is matched in a specific location with image I as determined by the algorithm. The CV_TM_CCOEFF_NORMED OpenCV template matching method uses the pattern matching algorithm illustrated in Equation (15) as follows:

. Lx ^ (T '(x \ y') - i '(x + x \ y + y'))

R (x, y) =.

τ'ίΛ y ') ² - Ly- Η * + + y') ² ₍₁₆₎ [00424] In another embodiment of this description, the template matching algorithm uses a Fast Fourier Transform (FFT). In some modalities, any of the methods of the OpenCV matchTemplateO function can be used, for example, CV_TM_SQDIFF, CV_TM_SQDIFF_NORMED, CV_TM_CCORR, and / or CV_TM_CCORR_NORMED.

[00425] CV_TM_SQDIFF uses the pattern matching algorithm illustrated in Equation (17) as follows:

(17) [00426] CV_TM_SQDIFF_NORMED uses the pattern matching algorithm illustrated in Equation (18) as follows:

_. - / (^ + ^ + /)) ² f = y / Lxfy 'EX /) ² - + z \ y + X ² (18) [00427] CV_TM_CCORR uses the pattern matching algorithm illustrated in Equation (19) as Follow:

^R (^ y) = 4- x ', y + y)) (19) [00428] CV_TM_CCORR_NORMED uses the pattern matching algorithm illustrated in Equation (20) as follows:

^R & y) = / =

- E ^ Λζ + Χν + Χ ₍₂₀₎

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114/190 [00429] In yet another embodiment of the present description, a gray-scale image of a free flow condition is compared with an image taken by the image sensor 63 of Figure 8 to determine whether a flow condition free exists. In some modalities, the template matching function with the OpenCV library can be used.

[00430] Refer now to Figures 20 and 21; in yet a further embodiment of the present description, the algorithm for determining when a free flow condition exists, for example, as performed by processor 90 of Figure 8, can use an algorithm to determine whether a template pattern matches a pixel network using edge detection followed by line detection. As shown in Figure 20, an image 98 is formed from an image 99 of Figure 21, using detected edge followed by line detection. The resulting lines can be used by processor 90 to determine that a free flow condition exists. As shown in Figure 20, the characteristic that appears after this processing by processor 90 are lines that have a different slope than the expected 45 ° slope of the background reference image. The lines that have the background image angle can be filtered from Figure 20, in some modalities. Lines can be detected as borders using a Canny algorithm as found in the OpenCV library. The Hough algorithm also found in the OpenCV library can be used to determine the slope of the lines.

[00431] A type of Hough transfer uses an algorithm described in Progressive Probabilistic Hough Transform by J. Matas, C. Galambos, and J. Kittler in 1998 (Algorithm 1). However, the following Alternative Hough transform can be used and is shown in the form of pseudocode in Table 1 (Algorithm 2). The algorithm 2

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115/190 randomly selects two pixels and calculates the Hough transform of the line that passes through these two points. Algorithm 2 is shown in Table 1 as follows:

TABLE 1

Alternative Hough Transform Pseudocode

1. If the image is empty, then exit.

2. Randomly select two pixels and update the accumulator

The. Required Operations

i. Two random numbers ii. An inverse tangent

3. Verify that the new location is higher than the l limit. If not, go to 0

The. Operations

i. A logical operation

4. Look along a corridor specified by the peak in the accumulator, and find the longest or continuous pixel segment or exhibiting a gap that does not exceed a given limit.

5. Remove the pixels in the input image segment.

6. Remove the vote from the accumulator of all pixels of the line that were previously voted.

7. If the line segment is longer than the minimum length, add it to the output list

8. Go to 1.

[00432] If the line comprises a proportion, p, of such points, then the probability that we will see a result in the representative (r, θ) -bin is p for Algorithm 1 and ² for Algorithm 2. Generally, in some modalities , a proportion test has at least 5 positive and 5 negative results. Assuming that it is more likely to see negative results than positive results, in some modalities, Algorithms 1 and 2 continue to search for lines until there are at least 5 positive results in a bin

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116/190 specific.

[00433] The probability of seeing a fifth positive result in Algorithm 1 after N> 5 tests is shown in Equation (21) as follows:

p ₁ (5 on N) = p (4 in N -1) · p = ^(N-1)! ₎ p '(1-p) ^N-5

4! (N - 5)! ^v (21), [00434] and the probability in Algorithm 2 is shown in Equation (22) as follows:

p ₂ (5 on N) = p (4 in N -1) · p ² = ^{(N 1)!} . p ¹⁰ (1-p ² ) ^N-5

4! (N -5)! ' ^r ' (22).

[00435] Table 2, shown below, shows the number of attempts to have a 50% chance of seeing 5 successes, p ₁ , _{50 and 2} , ₅₀ , as well as the number of attempts to have a 90% chance of seeing 5 successes. see 5 successes, p1,90 and p ₂ , 90.

Table 2

P Pi, 50 ^p 1.90 ^p 2.50 ^p 2.90 ^r 50 ^r 90

0.5 9 14 20 31 2.22 2.21 0.25 19 30 76 127 4 4.23 0.125 39 62 299 511 7.67 8.24 0.0625 76 127 1197 2046 15.75 16.11

[00436] Table 2 shows that the increase in the number of attempts between Algorithm 1 and Algorithm 2 to see 5 positive results is approximately.

[00437]

There must be 1 positive result on trials when the proportion is p.

[00438] The computationally expensive operation of Algorithm 2 is, in some modalities, the tangent arc function, which can be approximately 40 CPU of. There are approximately 2N floating point operations in the equivalent step of Algorithm 1. The

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117/190 Hough transform of a 640x480 pixel image with full resolution has N equal to 2520, while the Hough transform of a 1080x1920 pixel image has N equal to 7020. This implies that Algorithm 2 has a speed advantage on Algorithm 1 when p is greater than 0.008 for a 640x480 image and when p is greater than 0.003 for a 1080x1920 image.

[00439] In some modalities, it is assumed that each bin in the Hough transform space is equally likely to be occupied in the presence of noise. This simplification speeds up the limitation decision; however, in some modalities, this assumption is not true. The primary effect of simplification is to underestimate the probability that is seen in values greater than one in the Hough transform with a corresponding probability of falsely declaring that a line for a specific combination of image size bin layout and Hough transform, the real odds can be pre-computed. This allows the false alarm rate to be minimized without a corresponding increase in computation. With additional restrictions on the type of imaging, even more accurate estimates of the probability of seeing a value in a Hough transform bin are possible.

[00440] There are additional forms of the Hough transform that parameterize different characteristics. For example, there is a parameterization of circles of three elements, (x, y, r), where x and y specify the center and r is the radius. Algorithm 2 can work using these parameterizations as well. For the circle example, Algorithm 2 would select three pixels randomly and calculate the circle passing through it.

[00441] Algorithm 2 would have a similar speed advantage for characteristics that comprise a suitably large portion of the total pixels considered. This would also have an advantage

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118/190 significant gem in required storage, since the Hough transform could be stored in a sparse matrix, whereas the analog of Algorithm 1 would require a full size matrix. [00442] Referring now to Figures 22-26, which illustrate various background patterns that can be used to detect a free flow condition or estimate the size of a liquid drop. Image sensor 103 can be used with the background patterns in Figures 22-26 and can be image sensor 11 in Figure 1, image sensor 68 in Figure 5, image sensor 63 in Figure 6, or the image sensor 63 of Figure 8, each of which may be coupled to a respective processor to process images from the image sensor, such as processor 15 of Figure 1 or processor 90 of Figure 8.

[00443] Figure 22 is a block diagram of an imaging system 100 for use with drip chamber 104 (e.g., drip chamber 4 of Figure 1) that has a bottom pattern 101 with strips and a light source 102 that shines on the strips from a location adjacent to an image sensor 103 according to an embodiment of the present description. Any drops or free flow flows within the drip chamber 104 distort the image made by the image sensor 103. A processor attached to the image sensor 103 (for example, processor 15 in Figure 1) can use the background pattern distortions 101 as captured by the image sensor 103 to estimate a flow rate and / or detect free flow conditions.

[00444] Figure 23 is a block diagram of an imaging system 105 for use with the drip chamber 104 that has a background pattern 101 with strips and a light source 102 that shines on the strips behind the background pattern 101 with respect to an opposite end of an image sensor 103 according to

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119/190 with an embodiment of the present description. Figure 24 shows an image of the image sensor 103 of Figure 23 when a drop distorts the background pattern 101 of Figure 23 according to an embodiment of the present description. Note that as shown in Figure 24, the strips of the background pattern 101 are distorted by the drop (or will be distorted by a free flow stream) inside the drip chamber 104 as captured in images by the image sensor 103. This distortion can be used to estimate the droplet size, to calculate the flow rate through a drip chamber, or to determine whether a free flow condition exists within the drip chamber.

[00445] Figure 25 shows a block diagram of an imaging system 106 for use with a flow meter that has a background pattern 107 with a checkered pattern and a light source 102 that shines on the strips behind of the background pattern 107 with respect to an opposite end in an image sensor 103 according to an embodiment of the present description. Figure 26 shows an image of the image sensor 103 of Figure 25 when a drop distorts the background pattern 107 of Figures 25-26 according to an embodiment of the present description. In yet another embodiment of the present description, a background pattern that has a plurality of random dots and / or circles can be used by an image formation system described herein.

[00446] Referring to Figures 22-26, the lens effect of a drop (ie, distortion of the background pattern of the vision of an image sensor) can be used to measure the radius of the drop. The drop radius corresponds to how much and what effect the drop has on any light that passes through it. By measuring the change to the calibration grid (ie, the background pattern) as seen through the drop, the radius, and with this the drop volume, can be calculated. For example,

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120/190 a test grid of a size known as seen through the drop could be measured optically and the radius inferred from this measurement. In some embodiments of the present description, the relationship between the radius and the drop can be calculated and / or can be determined using an empirically generated lookup table.

[00447] Figures 27-28 show a flow chart illustrating a method for estimating the volume of the drop within a drip chamber according to an embodiment of the present description. That is, Figures 27-28 illustrate a method 214. Method 214 will also be described with reference to Figures 29-37. Figures 29-31 and 33-36 illustrate images used or generated by a flow meter to estimate a drop volume within the drip chamber according to an embodiment of the present description. Figures 32 and 37 illustrate a pseudocode that can be used by the method 214 of Figures 27-28.

[00448] Method 214 of Figures 27 and 28 can be implemented by flow meter 7 in Figure 1, flow meter 67 in Figure 5, the imaging system 78 in Figure 6, the imaging system 84 of Figure 8, or another flow meter or an image formation system described here (each with or without a background pattern and / or with or without active lighting).

[00449] Method 214 includes acts 200-213. Act 200 determines a baseline of a drop that forms in an opening of a drip chamber. Act 201 captures a first image. The first image can be captured using a uniform backlight. In some embodiments, a first image can be captured using a background pattern and / or an exposure algorithm as described herein. Acts 200 and 201 can be performed simultaneously. Figure 29 shows an image with the baseline 215 superimposed. Baseline 215 can be a predetermined group

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121/190 pixels or can be generated using fiducial markers arranged over the drip chamber opening and / or over a background pattern (not shown in Figure 29). The first image is used by method 214 to initialize a background image, p _i , _j , a network of variances, s _i , _j , and a network of integers, I _i , _j . The background image can be i by j pixels, while the network of variances and the network of integers can be 2-D networks that also have a size of i by j.

[00450] Act 202 identifies the drop within the first image and a predetermined band near the edge of the drop (for example, the band can be a predetermined number of pixels beyond the edge of the drop). Act 203 initializes a background image by adjusting each pixel to the same value as the first image (for that respective location) unless it is within the identified drop or a predetermined band near the edge of the drop. Act 204 sets the pixels within the drop region or within the predetermined band to a predetermined value. Figure 30 shows an example of a background image created after startup. In the exemplary image of Figure 30, the area of the drop and a band beyond the edge of the drop, generally referred to as 216, is adjusted to a predetermined value, for example, 140.

[00451] For example, when the method creates the first background image, each pixel in the background image that is part of the drop or a band outside a drop edge is set to a standard limit value, for example 140 of a range intensity 0-255.

[00452] Act 205 initializes the integers in the network from integers to zeros. Act 206 initializes the values within the network of variances for zeros. The network of integers is the same size as the image. The integer network counts how often each pixel of the background image has been updated with the new information and is initialized to all zeros. The network of variances (for example, a data type network

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122/190 double) is also the same size as the background image and contains an estimate of the variance of the intensity of each pixel within the background image.

[00453] Act 207 captures another image, and Act 208 identifies the drop in the other image and another predetermined band near an edge of the drop. Act 209 updates the background image, the network of integers, and the network of variances.

[00454] As additional images are captured, the background image can be updated. For example, when an image is collected by the system, the background algorithm evaluates all pixels. If a pixel is considered part of the drop or its guard band, then its value in the background image is not changed.

[00455] If a pixel is not considered part of the drop or its guard band: (1) if the corresponding pixel integer in the integer network is zero, the pixel value in the background image is set equal to the pixel value in the input image; or (2) if the pixel count is greater than 0, then the background image value for that pixel is updated using a low pass filter. In some embodiments, any filter style can be used, such as a high pass filter, a band pass filter, etc. A low-pass filter that can be used is illustrated in Equation (23) as follows:

P = P (1 - a) + a P background, /, j background, /, j \ background) background input, /, j (23).

[00456] In addition, the network of variances can be updated using Equations (24) as follows:

σ ² = (P _- P) ² temp (background, /, j input, /, j J ^S background, i, j ^ background,;, j ( ¹ ^ background ^{) +} ^ background ^S temp (24) [00457] Note that the filter used for both operations is an exponential filter, however, in additional modalities, other filters

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123/190 can be used, like other low-pass filters. The variance estimate can be performed in any known way or using a substitute for the estimate, for example, using standard deviation.

[00458] The new estimates of each of the background intensity of each pixel (average value), the number of images used to update the average and variance of each pixel and the variance of each pixel (for example, an approximation for the variance true and / or a value that is proportional to the variance) are used to update the networks. That is, each additional captured image can be used to update the background image, the network of integers, and the network of variances. After several images have been processed, the background image may look like Figure 31. Note that this image still has a region (the uniformly medium gray area, generally referred to as 217) where the pixels have never changed from the initial threshold value. This region was considered part of the drop or its guard band in each image.

[00459] Act 210 compares another image (for example, a current or more recent image) with the background image and identifies a plurality of pixels of interest. Act 211 determines a subset of pixels within the plurality of pixels of interest that correspond to a drop.

[00460] The comparison of act 210 compares another image pixel by pixel with the background image. From this comparison comes a network of the same size as the image where each pixel has a value of zero or not zero (255).

[00461] Act 210 can be implemented by the pseudocode shown in Figure 32. That is, the determination of this limit value is made according to the following: if the input pixel is to the left or to the right of the base line in the image, then its output value is set

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124/190 set to zero (Line 1); if the background count network of the input pixel indicates that less than a predetermined number of images (for example, 100) was used to make the background value of this pixel (Line 2), then: if the pixel intensity of input is less than the threshold intensity (for example, 140 in a range of 0-255), then set the pixel output value to nonzero (255) (Line 2a); or if the intensity of the input pixel is greater than or equal to the limit intensity, then set the output value of the pixel to zero (Line 2b); and if the input pixel background count network is greater than the predetermined number of images (Line 3), then: if the square of the difference between the input pixel intensity and background pixel intensity is greater than the pixel background variance estimate times a constant ^g , then set the pixel output value to nonzero (255) (Line 3a) (that is, if the difference between the current pixel value and the background image is greater than ^g , so the pixel is distinct); or if the square of the difference between the input pixel intensity and background pixel intensity is less than or equal to the pixel background variance estimate times a constant ^g , then set the pixel output value to zero (see Line 3b). Line 3 captures portions of the image that are altered by the presence of a drop, but which are made at a greater intensity.

[00462] When act 210 is implemented as an algorithm, the algorithm is initialized, and the input and output of this limiting algorithm will look like the images in Figures 33 and 34, respectively. As the number of images used in the estimation of the background image is initially small, the only criterion applied is shown as lines (1) and (2) above because there were not enough images used for the integer network to have a value beyond the limit. for certain respective pixels. This can result in many low

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125/190 x intensity being identified as distinct, including dimly lit edges and condensation on the chamber walls. [00463] After sufficient images have been assembled so that most (or all) of the pixels in the background image were generated with a sufficient number of pixels, the lines (3), (3a), and (3b) of Figure 32 are used. After applying the limit, the background is largely black with an occasional noisy pixel exceeding the limit of variance, as shown in Figures 35 and 36 (which show an image captured by the camera and the results of the comparison algorithm described above, respectively).

[00464] As previously mentioned, after act 210, act 211 determines which of a subset of pixels within the plurality of pixels of interest corresponds to a drop. Act 211 can be implemented by the pseudocode shown in Figure 37. That is, the limit image is passed to an algorithm which finds the connected component that represents the drop as illustrated by the pseudocode in Figure 37.

[00465] The binary image after processing the pseudocode of Figure 32 is evaluated to find the binary component which occupies the space given by the drop. The algorithm is passed in the location of a pixel on the baseline which is white (or this is passed by the central pixel of the longest length of contiguous white pixels on the line).

[00466] Since the algorithm has an initial white pixel, it executes the illustrated pseudocode algorithm shown in Figure 37. The pseudocode determines locations that include white pixels that have a path to the baseline (that is, a pixel path White). Line 1 pushes the location of the first pixel over a stack. Line 2 performs a wait loop while the stack is not empty. The waiting loop includes lines (2a) - (2d). Line 2a makes salt

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126/190 take the next location (* ' ^J ) off the stack. Line 2b makes the output pixel value white (* ' ^J ). Line 2c examines the eight pixels adjacent to (* ' ^J ). Line (2ci) is a statement if, and if the adjacent input pixel is white, but the output pixel is black, line 2c adds the location on the stack. Line 2d returns to line 2 to continue the wait loop (if the stack remains empty). [00467] This algorithm will set all output locations to white which may be connected at the location of the input pixel by a continuous path of white input pixels. The left drop limit is found going down through each line of pixels from the left edge until the algorithm finds a white pixel. The right boundary is found down the right side of the image until it finds a white pixel. The first line where it is possible to descend from the left edge to the right edge without finding a white pixel is where the drop is considered to end.

[00468] The pseudocode shown in Figure 37 is a one-pass version of a connected component identification algorithm. However, other connected component identification algorithms or other suitable algorithms can be used to determine which pixels correspond to the drop.

[00469] Act 212 of Figure 28 performs a rotation operation on the subset of pixels. Act 213 estimates a droplet volume within the drip chamber by counting the number of pixels within the rotated subset of pixels. The total number of pixels within the 3-D version of the drop is counted; and since each pixel corresponds to a distance, the number of pixels can be used to estimate the volume of the drop.

IMAGE FORMATION SYSTEM OPTICS [00470] Figures 38-42 facilitate the following description of the image optics

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127/190 an image formation system described here. For example, an image sensor described herein may be an image sensor cube manufactured by OmniVision of 4275 Burton Drive, Santa Clara, California 95054; and, for example, the image sensor hub may be one manufactured for telephone image sensor applications. In some embodiments of the present description, an image sensor described here can use a fixed focus and have a depth of field (DOF) of 15 centimeters to infinity.

[00471] The image sensor may have the turbidity circle of an image point formed in the image sensor range entirely contained within the area of a single pixel. The focal length of the image sensor lens can be 1.15mm, the F # can be 3.0, and the aperture of the image sensor lens can be 0.3833mm. A first-order approximation of the optical system to one or more of the image sensors can be made using Matrix equations, where each ray, r, is represented as the vector described in Equation (25) as follows:

(25).

[00472] In Equation (25) above, h is the height of the ray at the entrance to the image sensor, and θ is the angle of the ray. Referring to Figure 38, when forming the image of a hypothetical point at a dim distance from the lens of one of the image sensors (which has a focal length f) and the lens is a dfp distance from the focal plane, the corresponding matrix, M _cam , which describes the image sensor is described by Equation (26) as follows:

1 d - 1 0 Γ1 d Ί M = fp 1 ₁ im cam 0 1 f ¹ 0 1

(26).

[00473] To find the location on the focal plane, fp, where the radius

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128/190 impacts, a matrix multiplication as described in Equation (27) as follows can be used:

f X h _r > = M < f '-X H. im 1 7 cam q l im

(27).

[00474] As illustrated in Figure 38, the diameter of the turbidity circle, Dblur, is shown as approximately the distance between two points shown in Figure 38. This distance is found by braking the point's radii, d _im , away from the lens on the axis optical geometry to the edges of the lens and then to the focal plane. These rays are given by the vectors shown in (28) as follows:

^D i Ί ± tan 2 * d.

im J (28).

00 [00475] As shown in Figure 39, the _blur circle, D _blur , is calculated and shown for a variety of lens separations for focal plane and lens separations for image. A contour map 77 is also shown in Figure 39. The x-axis shows the distance in microns between the focal plane and a point located at a focal length away from the lens of an image sensor. The y-axis shows the distance in meters between the lens and the point having the image formed. The values that create contour map 77 are the turbidity size divided by the pixel size; therefore, anything about 1 or less is sufficient to form the image. As shown in Figure 39, the focal plane is located at a focal length and an additional 5 micrometers away from the lens.

[00476] The image sensor can use a second lens. For example, an image sensor can use a second lens to

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129/190 create a relatively greater depth of field and a relatively greater field of view. The depth of field using two lenses can be calculated using the same analysis as above, but with the optical matrix modified to accommodate the second lens and the additional distances, which is shown in Equation (29) as follows:

M sys

0 cam

1d lens lens im (29).

[00477] Figures 40 and 41 illustrate the field changes with the separation between the lens and the image sensor and the corresponding change in the focus of the image sensor. Figures 40 and 41 show the turbidity circle divided by the pixel size. Figure 40 shows the turbidity circle divided by the pixel size when a 20mm focal length lens is used. Figure 41 shows the turbidity circle divided by the pixel size when a 40mm focal length lens is used. The corresponding fields of view around the optical geometric axis for the corners of the two configurations in Figures 40 and 41 are shown in the Table in Figure 42.

[00478] As shown in Figure 42, in some modalities, the image sensor can use a lens with a focal length from 40 mm to 60 mm; this configuration may include placing an image sensor approximately 50.8 mm (2 inches) from the focus. In other embodiments of the present description, other configurations can be used including those not shown in Figure 42.

[00479] For example, the following analysis shows how depth of field can be adjusted for an image sensor using a focal length lens, f, a distance, z, from the focal plane, and a distance, d, from a point in space; a system matrix is shown in Equation (30) as follows:

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130/190 (30).

M =

z  1 0 " 1 d 1 1 _ f 1 0 1

[00480] Equation (30) reduces to Equation (31) as follows:

(31).

[00481] Equation (31) reduces Equation (32) as follows:

_ z f _ x f (32).

[00482]

Considering the points on the geometric axis points, all heights will be zero. The point on the focal plane where different rays will impact is given by Equation (33) as follows:

(33).

[00483] As shown in (33) above, θ is the angle of the radius. The perfect focus point is given by the lens manufacturer's equation given in Equation (34) as follows:

= 1 1 f ⁽³⁴⁾ .

[00484] Equation (34) can be repositioned to derive Equation (35) as follows:

^fz z _ f ⁽³⁵⁾ .

[00485] Inserting d from Equation (35) in Equation (33) to show the point of impact results in Equation (36) as follows:

^{fz z} _ ^f fz < ^{z f} f ² z + fz ² _ f ² z _ fz ¹

Θ = + ---— Θ = 0 (36).

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131/190 [00486] All rays that leave this point impact the focal plane on the optical geometric axis. As shown in Equation (37), the situation when the image sensor is moved a distance d from the focus is described as follows:

fz z - f fz z - f

2 2 2 2 2 f z + fzd - f d + fz - f z - fz - dz + fdz

------------------------------------- f (z - f) = ^f - f ^{2 - z 2} ₊ ^f dq = - ^(f of f (z - f) f (z - f) = f ^dq (37).

[00487] Equation (37) shows that by properly positioning the image sensor lens with respect to the focal plane, we can change the depth of field. In addition, the point size depends on the magnitude of the angle θ. This angle depends linearly on the opening of the vision system created by the image sensor.

[00488] In addition or alternatively, according to some modalities of the present description, an image sensor can be implemented adjusting for several parameters, including: the distance to the focus since it affects the compactness, alignment, and sensitivity of the image system. vision for the environment; the system's field of view; and the separation of lens - focal plane as it affects tolerances on the alignment of the system and the sensitivity of the system to the environment.

FLOW METER MODALITIES WITH OR WITHOUT VALVES CONNECTED TO THIS [00489] Referring to the drawings, Figures 43 and 44 show a flow meter 58 coupled to a drip chamber 59. As described below, flow meter 58 can optionally include one

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132/190 free flow detector component 12 (see Figure 1) according to an embodiment of the present description. In addition, alternatively, or optionally, flow meter 58 may include a flow rate estimator component 13 (see Figure 1) according to some embodiments of the present description. Figure 43 shows flow meter 58 with closed door 62, and Figure 44 shows flow meter 58 with open door 62. Flow meter 58 can be flow meter 7 in Figure 1 with valve 6 or without valve. Flow meter 58 includes a start button 60 and a stop button 61. In addition or optionally, flow meter 58 can include a return valve to stop the fluid from flowing through it or can signal another valve to stop the fluid in response to error conditions.

[00490] Flow meter 58 optionally includes image sensors 63 and 64 that can estimate fluid flow and / or detect free flow conditions. Although the flow meter 58 includes two image sensors (for example, 63 and 64), only one of the image sensors 63 and 64 can be used in some modalities. Image sensors 63 and 64 can image a droplet while being formed inside the drip chamber 59 and estimate its size. The droplet size can be used to estimate fluid flow through the drip chamber 59. For example, in some embodiments of the present description, image sensors 63 and 64 use an edge detection algorithm to estimate the size contour a drop formed within the drip chamber 59; a processor in it (see processor 15 in Figure 1, processor 75 in Figure 5, or processor 90 in Figures 6 or 8) can assume that the contour is uniform from each drop angle and can estimate the size of the contour drop. In the exemplary mode shown in Figures 43 and 44, the two image sensors

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133/190 and 64 can average the two contours together to estimate the size of the drop. For example, the algorithm can average the measured contours of the two image sensors 63 and 64 to determine the drop size. Image sensors 63 and 64 can use a reference background pattern to facilitate recognition of the drop size as described herein.

[00491] In another embodiment of the present description, image sensors 63 and 64 form the fluid image to determine whether a free flow condition exists. The image sensors 63 and 64 can use a background pattern to determine if the fluid is flowing freely (i.e., the drops are not forming and the fluid is flowing through the drip chamber 59). As previously mentioned, although the flow meter 58 includes two image sensors (for example, 63 and 64), only one of the image sensors 64 and 64 can be used in some modalities to determine if a free flow condition exists and / or to estimate fluid flow through the drip chamber.

[00492] In addition or alternatively, in some embodiments of the present description, another image sensor 65 monitors the fluid tube 66 to detect the presence of one or more bubbles within the fluid tube. In alternative modalities, other bubble detectors can be used in place of the image sensor 65. In still additional modalities, no bubble detection is used in the flow meter 58.

[00493] Referring now to the drawings, Figure 45 shows a flow meter 218 coupled to a drip chamber 219 according to an embodiment of the present description. The drip chamber 219 is attached to the flow meter 218 via couplers 410. A backlight 220 shines light through the drip chamber towards the image sensor 221 (shown in

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134/190 bypassed).

[00494] The flow meter 218 can transmit a flow rate electronically to a monitoring client 8 (see Figure 1). In addition or alternatively, in some optional embodiments, the flow meter 218 may include a display that displays a flow rate (for example, a touch screen, an LED display, and the like). The flow meter 218 can be coupled to a rod 223 through clamps 222.

[00495] In some embodiments, the flow meter 218 may be coupled to an actuator which is coupled to a valve (not shown in Figure 45) to form a closed loop system (for example, control component 14 in Figure 1, such as a PID, bang-bang, neural network, or fuzzy logic control system) to regulate the flow of fluid through the drip chamber 219.

[00496] The flow meter 218 may use any flow algorithm described herein and may include any imaging system described herein. In addition or alternatively, flow meter 218 may include a free flow detector component (for example, the free flow detector component 12 of Figure 1).

[00497] Figure 46 shows a flow meter 224 and a pinch valve 225 coupled to body 226 of flow meter 224 to control the flow of fluid to a patient according to an embodiment of the present description. The flow meter 224 includes an image sensor 227 and a backlight 228.

[00498] The image sensor 227 forms the image of a drip chamber 229 and can receive illumination to the backlight 228. The flow meter 224 includes a support member 230 coupled to a coupler 231 that couples the drip chamber 229 flow meter 224.

[00499] The flow meter 224 can implement any estimate

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135/190 flow rate painter described herein (for example, the flow rate estimator component 13 of Figure 1) and / or a free flow detector described here (for example, the free flow detector component 12 of Figure 1). The flow meter 224 can use the pinch valve 225 in a closed loop mode to control the flow of fluid to a patient (for example, using a control component 14 as shown in Figure 1).

[00500] The tightening valve 225, as is most easily seen in Figure 47, is coupled to an axis 233 which is coupled to an actuator 234. Actuator 234 can be a solenoid or any actuator that can move the tightening valve 225 towards a 335 tube.

[00501] Figure 48 shows a flow meter 336 and a tightening valve 225 according to an embodiment of the present description. The flow meter includes two image sensors 337 and 338. The flow meter 336 can use the pinch valve 225 in a closed loop return configuration. Flowmeter 336 can implement a volume estimation algorithm described here using both image sensors 337 and 338 to estimate fluid flow through drip chamber 229. For example, flowmeter 336 can average the two volumes together for use in the loopback.

[00502] Figure 49 shows a flow meter 339 and a valve 340 coupled to an actuator 341 to control the flow of fluid to a patient according to an embodiment of the present description. The flow meter 339 of Figure 49 is similar to the flow meter 224 of Figure 46; however, the flow meter 339 of Figure 49 includes a valve 340 that has elongated, curved support members 342 and 343 (see Figures 50A-50B) [00503] The flow meter 339 includes an image sensor 227 and

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136/190 a backlight 228. The image sensor 227 forms an image of a drip chamber 229 and can receive backlight illumination 228. The flow meter 339 includes a support member 230 coupled to a coupler 231 that couples drip chamber 229 on flow meter 339.

[00504] The flow meter 339 can implement any flow rate estimator described here (for example, the flow rate estimator component 13 of Figure 1) and / or a free flow detector described here (for example, the free flow detector component 12 of Figure 1). The flow meter 339 can use valve 340 in a closed loop mode to control the flow of fluid to a patient (for example, using control component 14 in Figure 1).

[00505] The flow meter 339 can actuate the actuator 341 to actuate the valve 340, which hereby regulates the fluid flowing through the IV tube 335 in a return configuration (ie, closed loop) using any algorithm of control.

[00506] Referring now to Figures 50A-50B, which show enlarged views of the valve 340 of Figure 49 according to an embodiment of the present description. Valve 340 includes an elongated, curved inner support member 343 and an elongated, curved outer support member 342. Tube 335 is positioned between support members 342 and 343.

[00507] The inner support member 343 includes a drum nut 344. The outer support member 342 is attached to the drum nut 344 via hooks 345. In some embodiments, the drum nut 344 is not attached to valve 340 and the inner support member 343 includes a hole for the threaded rod or screw 347 to slide through. External support member 342 also has hooks 348 to secure it to a frame 349 of actuator 341. Actuator 341 includes a shaft 346 coupled to a screw 347. According to

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137/190 the actuator 341 rotates the shaft 346, the screw 347 can rotate to push the drum nut 334 towards the actuator 341. That is, the hooks 345 and the drum nut 334 move in the direction of the hooks 348 and the frame 349 because the internal and external support members 342 and 343 are flexible.

[00508] As support members 342 and 343 are compressed, tube 335 becomes compressed because it is positioned between support members 342 and 343. Compression of tube 335 restricts the flow of fluid through tube 335. A valve 340 compresses a length of pipe 335 that is substantially greater than the diameter of pipe 335.

[00509] Figures 51A-51D show several views of a flow meter 350 with a monitoring client 358, a valve 352, a drip chamber 357, an IV bag 411, and a fluid tube 412 according to an embodiment of this description. Flow meter 350 includes a receiving portion 351 for receiving valve 352. Valve 352 includes two elongated, curved support members 353 and 354.

[00510] The flow meter 350 includes an image sensor 355 and a backlight 356 that can monitor the drops formed inside the drip chamber 357. The flow meter 350 can use the image sensor 355 to implement an algorithm of flow rate estimator described here (for example, the flow rate estimator component 13 of Figure 1) and / or implementing a free flow detector described here (for example, the free flow detector component 12 of Figure 1 ).

[00511] The flow meter 350 includes a base 359 that can form a dock to receive the monitoring client 358. The monitoring client 358 can be a smartphone, or other electronic computing device (for example, a device based on

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Android, an Iphone, a tablet, the PDA, and the like).

[00512] The monitoring client 358 can contain software in it to implement a free flow detector, a flow rate estimator, a control component, an exposure component, etc. (for example, the free flow detector component 12, the flow rate estimator component 13, the control component 14, the exposure component 29 of Figure 1) and can contain one or more transceivers (for example, the transceiver 9). In addition or alternatively, the base 359 of the flow meter 350 can implement these items.

[00513] For example, the flow meter 350 can implement a free flow detector, a flow rate estimator, a control component, an exposure component, etc. using internal software, hardware, electronics, and the like. The flow meter 350 can implement a closed loop return system to regulate the fluid flowing to a patient by varying the fluid flowing through valve 352.

[00514] As is easily seen in Figure 51B, valve 352 includes an inner support member 354 and an outer support member 353. Inner support member 354 is coupled to a drum nut 360 and a drum 361. In in some embodiments, the drum nut 360 is not coupled to the inner support member 354, and the inner support member 354 includes a hole for the threaded shaft 362 to slide through.

[00515] A threaded shaft 362 (for example, a screw) rotates freely within a bearing located inside the drum 361 and engages a threaded nut inside the drum nut 360 to push or pull the drum nut 360 in relation to the drum 361 by turning the button 363 (for example, the actuator is a lead screw that has a button for actuating the lead screw). The 363 button

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139/190 can be manually rotated.

[00516] In addition or alternatively, valve 352 can be fitted within the receiving portion 351 which includes a rotating member 364 that engages the button 363 within the receiving portion 351 (see Figure 51C). The rotation member 364 couples the rotation button 363 to actuate the valve 352. The rotation member 364 can be coupled to an electric motor which rotates the rotation member 364. The electric motor (not explicitly shown) can be controlled by the flow meter 350 in a closed loop configuration to achieve a target flow rate of fluid flowing to a patient.

[00517] Figures 52A-52D show several views of another flow meter 365 with a valve 352, a drip chamber 357, and a fluid tube ditch 413 that has a receiving portion 351 to receive a valve 352 accordingly with an embodiment of the present description. The flow meter 365 of Figures 52A52D is similar to the flow meter 350 of Figures 51A-51D; however, the base 359 keeps the monitoring client 358 in an upright position. In addition, the receiving portion 351 is opposite the base 359 of the monitoring client 358 (see Figures 52B and 52C).

[00518] Figure 52D shows an enlarged view of valve 352 coupling the receiving portion 351. The button 363 couples a rotation member that is internal to the base 359 (not shown in Figure 52D) that is coupled to a motor (neither shown in Figure 52D). [00519] Figure 53A shows another view of valve 352 of Figures 51A-51D and 52A-52D, and Figures 53B-53C show two exploded views of the valve of Figure 53A according to an embodiment of the present description.

[00520] As shown in Figures 53A-53C, valve 352 includes an internal support member 354 and an external support member 353.

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A tube can be inserted through holes 366 and 367 to position the tube between support members 354 and 353.

[00521] Knob 363 can be rotated to turn screw 362. Rotating screw 362 causes drum nut 360 to move towards partial drum 363 to compress a tube positioned between support members 353 and 354. O partial drum 363 includes two sides, however, there is a space to hold the end 600 (for example, the cover) of screw 362 securely within the space (for example, a complementary space). Figure 54 shows the valve 352 in manual use and attached to a pipe 368.

[00522] Figure 55 shows a valve 369 that includes two flexible members 370 and 371 according to an embodiment of the present description. The flexible members 370 and 371 can be two flexible plates. Flexible member 371 can include holes 373 and 374 for a tube 372 to be positioned between flexible members 370 and 371.

[00523] The flexible members 370 and 371 are coupled together through two connector members 377 and 378. The connector members 377 and 378 are coupled to coupling members 376 and 375, respectively.

[00524] The actuation of valve 369 can be by a linear actuator that pulls coupling members 375, 376 towards each other or away from each other. The linear actuator (not explicitly shown) can be a screw type actuator, piston actuator, or other actuator. In some embodiments, one of the coupling members

375 and 376 can be attached to a stationary bracket while the actuator is attached to Another of the coupling members 375 and

376 and other stationary support for pulling coupling members 375 and 376 together or apart.

[00525] Figures 56A-56C show several views of a valve 380 that has two elongated, curved support members 381 and 382

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141/190 with one of the elongated support members 381 having a plurality of edges 387 adapted to couple a tube positioned between the support members 381 and 382, according to an embodiment of the present description.

[00526] Valve 380 has both support members 381 and 382 coupled to a coupling member 383 at one first end and a second coupling member 384 at the other end. That is, coupling member 384 surrounds a screw 385, and coupling member 383 includes internal threads for pulling coupling member 383 towards or away from a button 386 when screw 385 is rotated by rotating the button 386. Figure 56B shows valve 380 when actuated to close the fluid flowing through a tube coupled between support members 381 and 382. Figure 56C shows support member 381 which has two holes 388 and 389 for receiving a tube. Also note that the support members 381 and 382 attach an off-center tube to a geometric axis of the screw 385, which is easily seen in Figure 56C. Holding the hole off the center of the 385 screw's geometric axis facilitates the free movement of the pipe.

[00527] Figures 57A-57C show several views of a valve 390 that has a ratchet 394 that couples a connection member 393 of valve 390 according to an embodiment of the present description, and Figures 57D-57E show two exploded views of the valve 390 of Figures 57A-57C. The ratchet 394 couples the connecting member 393 interacting with a gear rack 397 arranged on it. A 602 finger (see Figures 57D and 57E) interacts with a gear rack 397 to provide the ratchet action. That is, the finger 602 can secure the gear rack 397 against a coupling finger on an opposite side of the holding finger 602. The valve 390 includes a support member 391 that has an end

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142/190 coupled to ratchet 394 and another coupled end hinged to a hinge 395. Valve 390 also includes a support member 392 that has hooks 398 that can engage the ratchet body 394.

[00528] As shown in Figure 57C, a tube 396 can be positioned between the support members 391 and 392, the hooks 398 can then be attached to the ratchet body 394, and the connection member 393 can be inserted into the ratchet 394 ( as shown in Figure 57B). As shown in Figure 57C, tube 396 is positioned against support member 391 through openings 399 and 400.

[00529] Ratchet 394 engages gear rack 397 so that ratchet 394 can be manually moved in the direction of joint 395 for ongoing fluid flow adjustments. Subsequently, a button (not shown) can be attached to ratchet 394 to make fine adjustments to the distance between ratchet 394 and hinge 395. In addition or alternatively, ratchet 394 may include a release button (not shown) to release the ratchet of connection member 393.

[00530] Figures 58A-58D show several views of a valve 401 having two elongated support members 403 and 404, a connecting member 405, and a screw-type actuator 407 according to another embodiment of the present description.

[00531] Support members 403 and 404 can be permanently molded together at their ends with the ends of connecting member 405. A tube 402 can be positioned between support members 403 and 404.

[00532] As the knob 408 is rotated, the screw type actuator 407 expands or contracts due to coupling with a threaded rod 406. Figure 58A shows the valve in an open position while Figure 58B shows the valve in a position closed.

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Note that tube 402 is squeezed along a substantial length of tube 402. Figures 58C-58D show valve 401 in the open and closed position, respectively, from a perspective view.

[00533] Figures 59A-59C show several views of a body 501 of a valve 500 (see Figure 59H for the assembled valve 500) according to an embodiment of the present description. The body 501 includes a first elongated, curved support member 502 and a second elongated, curved support member 503. The first support member 502 includes raised holes 504, 505 for securing a tube between the support members 502 and 503.

[00534] The body 501 also includes a first connector 506 that is coupled to the support members 503, 504 at one end, and a second connector 507 that is coupled to the other ends of the support members 503, 504.

[00535] The first connector 506 is coupled to one end of the support members 503, 504 to a first end 508 of a connection member 509. The second connector 507 includes a hole 510 to position the second end 511 of the connector member 509 through it (as is easily seen in Figure 59B).

[00536] When a tube is positioned between the support members 502, 503, the movement of the second connector 507 in the direction of the first connector 506 compresses the tube arranged between the support members 502, 503. As the second connector 507 moves in the direction of the first connector, hole 510 of the second connector 507 allows the second end 511 of the connector member 509 to slide freely into it.

[00537] Figures 59D-59G show several views of a button 512 for use with the body 501 shown in Figures 59A-59C according to an embodiment of the present description. The 512 button

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144/190 includes a ratchet 513 defined by four fingers 514. Each of the fingers 514 included a threaded surface 515 for engaging a threaded connection member 509. The fingers 514 are arched in the direction of a hole 516 in the center of the button 512. The button 512 also includes fingers 517 that couple the second connector 507 (see Figure 59H). In some embodiments, the body 501 includes a recess 510 for receiving the fingers 517 of the second connector 508.

[00538] Figure 59H shows a valve assembly 500 including body 501 shown in Figures 59A-59C coupled to button 512 of Figures 59D-59G according to an embodiment of the present description. The button 512 is slid over the threads of the connecting member 509. The fingers 514 couple the threads of the connecting member 509 and the ratchet over the threads of the connecting member 509. That is, the button 512 is freely movable in the direction of the first end 508 of connection member 509 along the threads of connection member 509, but cannot be moved away from the first end 508 of connection member 509 without turning knob 512. That is, button 512 can be placed over the member connection 509 to provide rough adjustment of valve 500 by roughly moving connectors 507, 508 towards each other to close valve 500. Since the threaded surfaces 515 of the four fingers 514 couple the threads of connection member 509, rotation of the button 512 or reduces or increases the flow of fluid within a tube. Each of the fingers 514 includes a threaded surface 515 for coupling the threads of the connecting member 509 so that the rotation of the button 512 moves the second connector 507 towards or away from the first connector 506 to thereby control the flow of fluid from a tube positioned between the support members 502, 503.

[00539] Figure 60 shows a valve 520 that has a guide protrusion 521 according to an embodiment of the present invention.

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145/190 description. Valve 520 is similar to valve 500 in Figure 59H, but includes guide protrusion 521 and a button 522 that has a first and second collar 523, 524. Button 522 also includes internal threads (not shown) to couple threads 525 of a 526 connecting rod. In some embodiments, the internal threads may be ratchet, and in other embodiments, the internal threads may be fixed without providing a ratchet action.

[00540] Figure 61 shows a motor 536 and a valve clamping structure 537 for coupling to valve 520 of Figure 60 according to an embodiment of the present description. The valve clamping structure 537 includes clamping fingers 528, 529, 530, 531 each having a curved portion 533 to fit over the collars 523, 524 of a button 522 (see Figure 62) within respective guide portions. necklace 534.

[00541] Referring now to Figures 60, 61, and 62, once the collars 523, 524 are sufficiently attached, the button 522 is free to rotate. That is, the collar 523 can be secured between the clamping fingers 528 and 530 with its respective collar guide portion 534 allowing the button 522 to rotate. Likewise, collar 524 can be secured between fixing fingers 529 and 531 within its respective collar guide portion 534 allowing the button 522 to rotate.

[00542] When valve 520 is attached to the valve clamping structure 537, the rotation of wheel 1537 (caused by engine 536) turns knob 522 of valve 520. As valve 520 flexes, protrusion 521 moves freely within the guide protrusion 535 or adjacent to protrusion guide 535. Figure 62 shows the valve of Figure 60 attached to the engine 536 through the valve clamping structure 537.

[00543] Figure 63 shows another engine 538 and valve fixing structure 539 for coupling to the valve of Figure 60 according to

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146/190 an embodiment of the present description. The valve clamping structure 539 includes a protrusion guide 540 adjacent to engine 538. Engine 538 is attached to wheel 541 to engage button 522 (see Figure 60).

[00544] Figure 64A shows a valve 542 that has a sliding collar 545 and several compression fingers 544 to regulate the flow of fluid through a fluid line 543 according to an embodiment of the present description. The base 546 is connected to all fingers 544. As the sliding collar 545 is moved over the compression fingers 544, the compression fingers 544 compress the tube 543 to prevent fluid flow within it.

[00545] The fingers 544 are coupled to a base 546 so that the base 546 and the fingers 544 surround the tube 543. The collar 545 is slidable away from the base 546 so that the fingers 544 compress the tube 543 which by means of this reduces an internal volume of tube 543 as the collar is moved. Reducing the internal volume of tube 543 reduces the flow of fluid through the tube. An actuator (not shown) can be attached to collar 545 to control the position of collar 545 (for example, a linear actuator may be attached to collar 545 and base 546). Figure 64B shows a cross-sectional view of the valve 542 of Figure 64A. Note that fingers 544 can be formed away from the tube near an opposite end of the base [00546] Figure 65 shows a valve 547 that has two curved surfaces 549 and 550 for positioning a tube of fluid 548 between them to regulate flow of fluid through fluid tube 548 according to an embodiment of the present description. As the surfaces 549, 550 are compressed together, the tube 548 is compressed between them. The two curved surfaces 549 and 550 can be compressed together using an actuator. Tube 548 can be rolled up dia

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147/190 several times around surface 549.

[00547] Figures 66A-66G show several views of a valve 551 that has a button 552 for moving a connecting member 553, which is locked in position after movement of the button 552, according to an embodiment of the present description.

[00548] Valve 551 includes an elongated, curved inner support member 554 and an elongated, curved outer support member 556. A button 552 is coupled hinged to the outer support member 56 via a pin 578. A 553 connecting member couples teeth 576 of button 552.

[00549] Connecting member 553 can be inserted into a hole at one end 555 of support member 556 so that rotation of button 552 will frictionfully lock a coupling finger 700 (see Figure 66G) into gear rack 558 connection member 553. Coupling finger 700 can engage teeth 576 to lock button 552 to thereby prevent rotation of button 552 unless sufficient torque exceeds the locking action of coupling finger 700. Finger retainer 577 is positioned on the other side of bore 571 to press connection member 552 against teeth 576 of button 552.

[00550] The inner support member 554 can pivot outwardly away from the outer support member 556 so that a tube can be loaded through the raised portions 559 and 560 (see Figure 66C). Inner support member 554 pivots away from outer support member 556 through dog bone connectors 561, 562, 701, and 702 as shown in Figure 66C. Thereafter, the inner support member 554 pivots back towards the support member 556 as shown in Figure 66D. Connecting member 553 is then inserted at one end 555 of outer support member 556 (an enlargement of the insert is shown in

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Figure 66E) which includes the coupling finger 700 that locks over the teeth 576 of the button 552 which temporarily immobilizes the connecting member 553 (see Figure 66G). The other end 581 of the connecting member 553 is locked into a hole 582 of an end 557 of the supporting member 556. The connecting member

553 can be hingedly connected at end 557. Knob 552 includes teeth 576 to move connecting member 553 in or out of end 555. However, when knob 552 is not moved, coupling finger 700 locks in motion of button 552 unless a predetermined amount of torque click finger 700 to the next tooth of teeth 576 on the inner portion of button 552.

[00551] As previously mentioned, the support member

554 can swing away from the outer support member 556 as shown in Figure 66C, which is facilitated by the dog bone connectors 561, 562, 701, and 702. The dog bone connector 561 includes a hinge hole 572 that couples a joint 563 and a joint hole 573 that couples to a joint 565. The dog bone connector 562 includes a joint hole 575 that couples to a joint 566 and a joint hole 574 that couples to a joint 566. The dog bone connector 701 engages joints 567 and 570, and the dog bone connector 702 engages joints 568 and 569 so that the end of the support member 556 also swings away from the inner support member 554 [00552] Figure 67 shows a 408 graph that illustrates performance vs. flow rates for a valve according to an embodiment of the present description. Graph 408 shows the operation of a valve that has elongated support members, such as, for example, valve 340 in Figures 49 and 50A-50B, valve 352 in Figures 51A-54, a

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149/190 valve 369 in Figure 55, valve 380 in Figures 56A-56C, valve 380 in Figures 57A-57E, valve 401 in Figures 58A-58D, valve 500 in Figure 59H, valve 520 in Figures 60- 60, valve 542 of Figures 64A-64B, valve 547 of Figure 65, and / or valve 551 of Figures 66A-66G. The x-axis of graph 408 shows the displacement between the ends of the valve support members, and the y-axis shows the flow rate (for example, caused by gravity and / or a pressure source). The valve response is a non-linear function, such as an S curve, a sigmoid curve, a Gompertz curve, or a generalized logistic function. These functions can be adjusted to match the valve and / or the valve can be adjusted to match one of the curves or functions.

[00553] Figure 68A shows a flow meter 703 using a binary optics 705 according to an embodiment of the present description. The flow meter 703 includes a camera 355 that captures one or more images to estimate a fluid flow rate through a drip chamber 357 using any sufficient method, for example, the methods described herein. The flow meter 703 includes a laser 704 that directs a laser beam over a set of binary optics 705. The set of binary optics 705 redirects and reshapes the laser beam through the drip chamber 357 and over the image sensor 355 so that the image sensor 355 sees a pattern, for example, the line network 85 shown in Figure 8 which can form strips as shown in background pattern 89 of Figure 10. The binary optics set 705 can form the strips using a plurality of ovals.

[00554] The 355 image sensor can include the filter to filter all frequencies except for the 704 laser frequency. For example, the 355 image sensor can include a pass filter

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150/190 band, optical that has a central frequency equal to (or approximately equal to) the optical frequency (or central frequency of the optical frequency) of the 704 laser.

[00555] The monitoring client 358 can be electrically coupled to laser 704 to modulate laser 704. For example, monitoring client 358 can turn on laser 704 only when predetermined pixels are being exposed and can turn off laser 704 when other pixels in addition to the predetermined pixels are being exposed.

[00556] The flow meter 703 optionally includes a first electrode 800 and a second electrode 801. The monitoring client 358 can be electrically coupled to the first and second electrodes 800, 801 to measure a defined capacitance between them. Under flow conditions, capacitance because relative permittivity is different for air and water. The monitoring client 358 can monitor changes that result from a flow condition with the 357 drip chamber by monitoring the capacitance between the first and second electrodes 800, 801 and correlating increases and / or decreases in capacitance beyond a limit as corresponding to or a flow condition and / or a non-flow condition. For example, if the capacitance between the first and second electrodes 800, 801 is higher than a threshold, a processor within the monitoring client 358 can determine that the drip chamber 357 is experiencing a flow condition.

[00557] In an alternative mode, the first and second electrodes 800, 801 are loop antennas. Monitoring client 358 uses a transceiver to monitor the magnetic coupling between loop antennas 800, 801. For example, the transceiver can transmit a coded message from one loop antenna on antennas 800, 801, to another on loop antennas 800 , 801 and then determine whether the

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151/190 encoded message was received successfully. If so, then a measurement of received signal strength indication (RSSI) can be made from the transceiver. See Figure 68B for an exemplary circuit. RSSI can be used to monitor the magnetic coupling between antennas 800, 801. If the magnetic coupling is above a limit, then the monitoring client 358 can determine that a flow condition exists within the 357 drip chamber. modalities a magnetic coupling change or a capacitive coupling change can be determined to be an indication that a flow condition has occurred.

[00558] Flow meter 703 may also include a safety valve 706. Figures 69A-69F show various views of the safety valve 706 that can be used with a flow meter, such as flow meter 703 in Figure 68 , according to an embodiment of the present description.

[00559] Figures 69A-69B show exploded views of a safety valve 706. The safety valve can also be referred to as a safety cut in this application. The safety valve 706 includes a solenoid 707, an interface structure 708, a tube housing 709, a spring 720, a face plate 712, a first axis 713, a second axis 714, a first occlusion arm 710, and a second occlusion arm 711. Face plate 712 includes a hole 715, and the tube housing 709 also includes a hole 819. Holes 715, 819 allow shaft 713 to slide into holes 715, 819.

[00560] Referring to Figure 69C, a tube can be placed at location 820 within tube housing 709 which places the tube at location 820 close to the first and second occlusion arms 710, 711, which are easily seen in Figure 69D . A spring 720 keeps the first and second occlusion arms 710, 711 indented

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152/190 when in the retracted state (as shown in Figure 69D), but stores energy so that a predetermined amount of movement of the first and second occlusion arms 710, 711 in the direction of tube 810 causes spring 720 to discharge its mechanical energy stored to cause the first and second occlusion arms 710, 711 to extend outward and occlude the tube at location 820.

[00561] The spring can be connected to the first and second axes 713, 714. The spring 720 pulls the first and second axes 713, 714 towards each other. The first and second occlusion arms 710, 711 are connected hinged together. As the first and second occlusion arms 710 and 711 are pivoted together at a pivot point that is off center of the axes 713, 714, the spring 720 pulling on the axes 713, 714 towards each other will remain stable in the recessed states (as shown in Figure 69D) until solenoid 707 causes arms 710, 711 to extend outward beyond a predetermined amount. As is easily seen in Figure 69E, a shaft 718 of a solenoid 707 can act through a hole 719 to push on the arms 710, 711 whatever causes the spring 720 to release its energy and occlude the tube at location 820 ( see Figure 69F for the case where the first and second occlusion arms 710, 711 are in the occlusion position).

[00562] Referring to Figure 69G, in some embodiments, a current-responsive material 717 may be coupled to the solenoid 707. The current-responsive material 717 may be configured for the solenoid so that the solenoid can couple the first occlusion arm 710 and the second occlusion arm 711 when the current responsive material 717 changes shape due to exposure to a current change. When current-responsive material 717 is exposed to a change in current, current-responsive material

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153/190

717 can apply force to solenoid 707. Subsequently, solenoid 707 can apply force to the firing mechanism to release the occlusion arms.

[00563] In another embodiment, as shown in Figure 69H, the first and second occlusion arms can be retained by magnetic force. In some embodiments, a first and second magnets 722, 723 may be oriented with aligned magnetic opposite poles (for example, north and south poles). The arms 710, 711 can be maintained in the recessed states using this attractive magnetic force. One of the two magnets can be rotated so that the magnets are reoriented so that the first and second magnets are oriented with equal magnetic poles aligned (for example, north and north poles or south and south poles). The alignment of equal poles causes the magnets to repel each other. The magnetic repellent force can be used to cause the arms 710, 711 to extend outward. In other embodiments, a permanent magnet 724 can be placed inside a coil 725, as shown in Figure 69I. In these embodiments, the arms 710, 711 can be retained in the recessed state using the magnetic force created by the magnet 724 and coil 725. The magnetic force can be overcome using a solenoid or some other element, causing the arms 710, 711 to be coupled and extend out beyond a predetermined amount. Figure 70 shows a flowchart illustrating a method 728 for estimating drop and / or flow growth within a drip chamber according to an embodiment of the present description. Method 728 includes acts 729-735. Figures 71A-71E show images taken by a flow meter with a template superimposed on it to illustrate the method in Figure 70. Note that template 727 is processed to determine a drop edge position in X and Y dimensions.

[00564] Act 729 captures an image of a drip chamber

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154/190 ment. The captured image can be the image 721 of Figure 71A. Act 730 positions the template within the captured image in a first position. For example, as shown in Figure 71A, a template 727 can be positioned within a predetermined position. Act 731 averages all pixels within template 727. Act 732 moves the template to a second position. For example, template 727 in Figure 71A can move the template in the Y direction (for example, downwards as seen in Figure 71A).

[00565] In act 733, the pixels within the template are used to determine a second average. In act 734, if a difference between the second average and the first average is greater than a predetermined limit value, determine that the template is located on the edge of a drop. For example, referring to Figure 71A, the template can be slowly lowered in the Y direction, until template 727 transitions from the edge of a drop to a portion of the image that does not contain the drop, in which case the average pixel value will transition abruptly from a dark average to a lighter average. When this transition occurs, the Y position of template 727 is considered to be at the edge of the drop (for example, Y1 in Figure 71A). In act 735, the second drop position is correlated with a drop volume. For example, the value Y1 can be associated with a drop volume in a lookup table. In some embodiments of the present description, multiple movements of the 727 template are necessary until the droplet edge is detected. For example, template 727 can be moved in the y direction one pixel at a time (or several pixels at a time) and multiple template movements 727 may be needed so that the drop's edge is detected. By monitoring the edge of the droplet, the growth of the droplet can be controlled by the flow meter to achieve a target flow rate (for example, the transition rate between Y1 in Figure 71A to Y2 in Figure 71B can

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155/190 be controlled by a PID control loop inside a flow meter). Figure 71B shows a location, Y ₂ , which corresponds to a drop growth relative to the location, Y1, of Figure 71A. Figures 72C-73E show how the sequential growth of a drop can be monitored.

[00566] Figure 72 shows a modular backlight set 740 according to an embodiment of the present description. Assembly 740 can be the backlight 18 of Figure 1 or it can be used as a backlight for any sufficient flow meter described herein. Assembly 740 includes a first circuit board 738, a second circuit board 739, a first backlight diffuser

736, and a second backlight diffuser 737.

[00567] The first circuit board 738 includes built-in light sources 822 that extend along the interface between the first backlight diffuser 736 and the first circuit board 738. The built-in light sources 822 shine light into the first diffuser backlight 736 which is directed outward as indicated by 821. Light 821 can be detected in the direction of an image sensor. The first backlight diffuser 736 only diffuses light when no pattern is formed when viewed by an image sensor.

[00568] The second circuit board 739 includes built-in lights 823 which are illuminated within the second backlight diffuser

737. The second backlight diffuser 737 creates a strip pattern that appears in light 821 when viewed by an image sensor. Therefore, a monitoring client (for example, the monitoring client 358 in Figure 51A) and / or the flow meter (for example, flow meter 7 in Figure 1) can select from a stripped background pattern (enabling recessed lights 823) and a strip-less background pattern (activating recessed lights 822).

[00569] For example, referring now to Figures 1 and 72, the meter

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156/190 of flow 7 can use the backlight set 740 in some specific modalities. Flow meter 7 can use a strip-less backlight pattern (activating the built-in LEDs 822 without activating the built-in LEDs 823) to monitor the growth of droplets and can switch to a stripped background pattern (activating the built-in LEDs 823 without activating the built-in LEDs 822) to detect flow conditions.

[00570] Figures 73A-73C show several views of a tube restoration apparatus 741 according to an embodiment of the present description. The apparatus 741 includes a drive gear 744 which is coupled to a first restoration gear 742. The first restoration gear 742 is mechanically coupled to the second restoration gear 743. A tube can be placed between the first and second restoration gears 742 , 743. Portions of the first and second restoration gears 742, 743 define a space 745 in which a tube can be positioned. Rotating the first and second restoration gears 742, 743 closes the distance between space 745 when the tube is positioned between the first and second restoration gears 742, 743. The transition from a non-restoration position to a restoration position is shown in Figure 73B to Figure 73C. For example, a tube may be positioned so that an occluder presses up against the tube at the bottom (as shown in Figure 73B). If the tube becomes distorted over time, a motor connected to drive gear 744 rotates gears 743 and 744, to press against the tube walls (as shown in Figure 73C) to restore the tube so that a section cross section of the tube is generally circular by compression over the tube wall portions that are expanded beyond a central geometric axis of the tube so that the tube is distorted to

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157/190 an oval shape, for example.

[00571] Figure 74 shows a system for regulating fluid flow 746 using a valve 747 that has two flexible strips 753 and 754 (see Figure 75); and Figure 75 shows the valve 746 of Figure 74 according to an embodiment of the present description. Optionally, a motor can be attached to valve 746 for control by a flow meter in one mode.

[00572] As shown in Figure 75, valve 747 includes two flexible strips 753, 754 in which a tube can be arranged between them, a guide shaft 752, two guiding members 749, 750, a screw 791, and a button 748 .

[00573] When the button 748 is turned, the screw 791 turns. Rotation of screw 791 pulls guide member 750 toward the nearest guide member 749 (because the furthest guide member 750 includes internal threads and screw 791 rotates freely within the nearby guide member 749). Guide 752 guides the movement of the farthest guide member 750. Guide 752 is coupled to the nearest guide member 749.

[00574] Figure 76A shows a valve 755 that uses a fluid-based bladder 758 according to an embodiment of the present description. Valve 755 includes two shells 756, 757, a bladder 758, and a piston 759. Piston 759 can be any source of fluid. Bladder 758 can be placed inside a cavity 764 and a tube can be placed through bladder 758 and positioned inside passages 760 and 761. Subsequently, the shell 757 can be placed over bladder 758 so that cavity 765 is placed over the bladder 758. The two shells 756, 757 can then be ultrasonically welded together, temporarily compressed together, and / or sufficiently held together. Thereafter, an actuator (for example, an actuator controlled by a flow meter here

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158/190 described) can be actuated to move the fluid in and out of the bladder 758 through piston 759.

[00575] Figure 76B shows a cross-sectional view of the assembled valve 755 of Figure 76A with two elastomeric fillers 1002, 1004 according to an embodiment of the present description. Elastomeric fillers 1002, 1004 help to hold tube 1000 in position and help restore tube 1000 when bladder 758 is deflated.

[00576] Figure 77 shows a system 766 for regulating fluid flow using a valve 769 that has two flexible strips 771, 772 (see Figure 79) actuated by linear actuator 822 according to an embodiment of the present description. Figure 78 shows linear actuator 822 acting on valve 769 to prevent fluid flow through a pipe 775. Valve 769 is coupled to two couplers 767 and 768. The closest coupler 768 moves with linear actuator 822 while the coupler furthest 767 is fixed in relation to a non-movable end of linear actuator 822.

[00577] Figure 79 shows an enlargement of valve 769 of Figures 77-78. The valve 769 includes two strips 771, 772 (which can be metal strips) on which the tube 775 can be arranged. The two strips 771, 772 of valve 769 can be coupled to a first end structure 773 and a second end structure 774. The first end structure 773 can be coupled to the farthest coupler 767 and the second end structure 774 can be coupled to the nearest coupler 768 (see Figures 77-78). A strand 770 or membrane can be wrapped around tube 775 so that when strips 771, 772 are straightened, strand 770 presses against the side walls of tube 775 to help round tube 775. The membrane can be a flexible but not stretchable material (or minimally stretchable material). Figu

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159/190 ra 80 shows an enlargement of the valve as shown in Figure 78. Note the holes 776 and 778 through which the cord 770 is threaded. Cord 770 (which may be metallic) is coiled around tube 775 so that when valve 769 opens, cord 770 restores tube 775.

[00578] Figure 81 shows several images for use to illustrate a method for estimating drop growth and / or fluid flow illustrated in Figures 82A-82B according to an embodiment of the present description. Figure 81 shows images 771-777 which are referred to below referring to Figures 82A-82B.

[00579] Figures 82A-82B show a flow chart illustrating a method 803 for estimating drop growth and / or fluid flow. Method 803 includes 804-818.

[00580] Act 804 captures a first image (for example, image 771 in Figure 81). The first image can be a gray scale image of the drip chamber. The drip chamber may be uniformly illuminated with a strip pattern on the bottom of the chamber (that is, there is no rear pattern on the top portion of the drip chamber).

[00581] Act 805 creates a first bounded image using a first image. The first bounded image can be the image 774 in Figure 81. The first bounded image can be made by comparing each pixel of the first image with a limit value (for example, setting a respective pixel of the bounded image to 0 if the respective pixel of the first image is above the limit or by adjusting a respective pixel of the image with limit to 1 if the respective pixel of the first image is below the limit). This Act is to highlight areas where there is water in front of the bottom.

[00582] In some specific modalities, the limit level is updated each time a new image is taken to ensure that

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160/190 a predetermined ratio of 1 to 0 pixels is maintained to highlight the drop. The ratio can be updated for use by Act 805 when used again or the update can adjust the limit until a predetermined ratio of 1 to 0 pixels is made and then use the first image with a limit for the rest of the 803 method.

[00583] Act 806 determines a set of pixels within the first bounded image connected to a predetermined set of pixels within the first bounded image. The predetermined set of pixels can be determined by marked fiducials on the drip chamber or an opening in which the drops are formed. The predetermined set of pixels can be a predetermined set of x, y values that correspond to pixels. Act 806 can use a connected component image analysis algorithm.

[00584] Act 807 filters all remaining pixels of the first bounded image that are not within the set of pixels. The filter operates on a pixel-by-pixel basis within the time domain to generate a first filtered image. The first filtered image is an estimate of a non-active portion (for example, a result of features not of interest in the image) of the first bounded image (image 774 in Figure 81). The filter can be any filter, for example, any filter described here.

[00585] Act 808 removes the pixels determined not to be part of a drop of the first bounded image using the first filtered image to generate a second image (for example, image 775 in Figure 81). A pixel within the second image will be set to 1 if the respective pixel in the first bounded image is 1 and the respective pixel in the first filtered image is less than 0.5; otherwise, the pixel will be set to 0.

[00586] Act 809 determines a second set of pixels within the second image connected to a set of pixels predetermines

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161/190 do within the second image to generate a third image (for example, image 776 in Figure 81). The third image identifies the second set of pixels within the second image. Act 809 finds the set of lit pixels in the second connected image in the predetermined set of pixels (for example, pixels representing the aperture in which the drops are formed).

[00587] Act 810 determines a first drop length by counting the number of lines containing pixels that corresponds to the second set of pixels within the third image. That is, the droplet length is determined to be equal to the last lit line in the set of pixels found in act 809. The first length corresponds to an estimated first droplet size.

[00588] Act 811 updates a background image using the first image. A low pass filter can be used to update the value of each pixel in the background image. An infinite impulse response filter can be used to update the background image using the first image. A pixel is only updated in the background image for the lines below the first length but a predetermined security zone. A pixel in the background image is updated by filtering the corresponding pixel value in the first image by low pass.

[00589] Act 812 creates a second image with a limit (for example, image 772 of Figure 81) comparing the first image with the background image. That is, the first image has the background image subtracted from it, and on a pixel-by-pixel basis, the absolute value of each pixel is set to 1 if it is above a second limit value and is set to 0 if it is below the second limit value to generate the second limit image.

[00590] Act 813 adds the lines of the second image with limit to create a plurality of sums of lines (see image 773 of Fi

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162/190 Figure 81). Each sum of lines corresponds to a line in the second bounded image.

[00591] Act 814 starts at a line position of the second boundary image that has a first sum of the plurality of sums corresponding to the first length. The line position is increased in act 815. Act 816 determines whether the present line position corresponds to a corresponding line sum that is below a limit, for example, zero. If not, then Act 815 is performed again until the line position corresponds to a corresponding line sum that is zero and then method 803 proceeds to act 817.

[00592] Act 817 determines whether a second length is equal to the present line position. The second length that corresponds to a second estimated drop size. Act 818 averages the first and second lengths to determine an average length. The average length corresponding to an estimated third drop size. By using the first and second lengths to determine an average length, the effects of condensation on the internal walls of the drip chamber are mitigated. That is, the purpose of creating two drop length estimates is to compensate for how much each length is affected by the presence of condensation. The first length tends to underestimate the drop length if the drop of condensation intersects the growing drop of the nozzle. The second length tends to overestimate the drop length if the drop of condensation intersects the drop that grows from the nozzle. its mean provides a better estimate when condensation is present. In the absence of condensation, the estimates are almost the same. In other embodiments, only either the first or second length is used to estimate the drop size.

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163/190 [00593] Figure 83 shows a flow chart of a 900 method for reducing condensation noise according to an embodiment of the present description. Method 900 includes acts 902-910.

[00594] Act 902 captures an image of a drip chamber. Act 904 performs a careful edge detection operation on the image to generate a first processed image. Act 906 performs an AND operation on a pixel on the first side of a geometry axis in the first processed image with a corresponding mirrored pixel on the second side of the geometric axis of the first processed image. That is, act 902 defines a geometric axis in the first process image, and performs an AND on each pixel on one side with a pixel on the other side, so that the pixel on the other side is symmetrical with the pixel on the first side. For example, an image of 40 (geometric axis X) by 40 (geometric axis Y) can have a geometric axis defined between pixel columns 19 and 20. The top, left pixel would be the pixel (1,1). A pixel at the location (1, 5) would be ANDed with a pixel at (40, 5). The resulting pixel would be used for both locations (1, 5) and (40, 5) to generate the second processed image.

[00595] After act 906 is executed, act 908 determines whether all pixels have been processed. Act 908 repeats act 906 until all pixels have been processed. Act 910 provides a second processed image that is the result of all AND operations.

[00596] Figure 84 shows another valve 2000 for use with a flow meter according to an embodiment of the present description. Valve 2000 is coupled to a portion of an inlet fluid line 2001 and a portion of an outlet fluid line 2002. A section of flexible pipe 2003 is coupled between the portion of an inlet fluid line 2001 and a portion of a line

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164/190 outlet fluid 2002 inside a rigid cylinder 2004. A fluid pump 2005 is coupled to the rigid cylinder 2004 to pump the fluid in and out of the rigid cylinder 2004. The rigid cylinder 2004 may include a fluid disposed therein , for example, a liquid.

[00597] An actuator 2007 controls a plunger 2008 from the pump 2005 to use the fluid inside the rigid cylinder 2004 to compress the hose section 2003 to control the flow of fluid between the portion of an inlet fluid line 2001 and a portion of a 2002 outlet fluid line. Actuator 2007 can be controlled by a processor (for example, processor 15 in Figure 1). By collapsing the hose section 2003, fluid flow that flows inside the hose section 2003 can be controlled by the actuation of the 2007 actuator.

[00598] Figures 85A-85C show another 8500 valve for use with a flow meter according to an embodiment of the present description. This embodiment uses a plunger 8512 and a substantially incompressible filling 8621 (the filling has been left out of Figures 85A-85C for clarity and is shown in Figure 86) to deform a flexible tube within which a flow is being controlled. The flexible tube can be an IV tube and can be arranged through holes 8518 (see Figure 85B) over the first shell portion 8504 and / or the second shell portion 8502. The substantially incompressible filling 8621 (see Figure 86) is contained within a rigid shell comprising a first shell portion 8504 and a second shell portion 8502. The first shell portion 8504 and the second shell portion 8502 are connected by a joint 8505 that allows a user to open the shell to insert and remove a flexible tube into which the flow of fluid is being controlled through it by valve 8500. Plunger 8512 couples the substantially incompressible filling 8621 through a hole 8511 in a first portion of

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165/190 shell 8504, finally deforming the tube.

[00599] The first shell portion 8504 and the second shell portion 8502 are secured in a closed position by a latch (8503, 8506) since the flexible tube is positioned inside the housing. The latch comprises the male component 8503 on the second shell portion 8502 and a female component 8506 on the first shell portion 8504. The male component 8503 extends out of the second shell portion 8502 on the opposite side of the joint as multiple fingers. The 8506 female component is a lever with an 8506a input end and an 8506b output end. The latch holds the shell 8502, 8504 closed by positioning the outlet end 8506b of the female component 8506 over the male component 8503, and rotating the female component 8506 over the top of the second shell portion 8502 as shown in Figure 85B. Connecting members 8501 connect the female portion 8506 to a first shell portion 8504 so that when the female component of the latch is turned closed, the outlet end 8506b of the rounded edge of the female component 8506 (i.e., the outlet end 8506b is a rounded edge) compresses against the male component 8503 of the latch 8503, 8506. This characteristic creates a force on the male component 8503 when the female portion 8506 is rotated, which squeezes the first shell portion 8504 and the second portion of shell 8502 together.

[00600] Plunger 8512 is guided into the first cup portion 8504 by a guide 8508 attached to the first cup portion 8504 and is actuated by a linear actuator 8510. The 8510 guide aligns the plunger 8512 with the hole 8511 in the first portion cup 8504. Actuator 8510 is attached to guide 8508 at one end of guide 8508 that is opposite the end of guide 8508 attached to the first cup portion 8504.

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166/190 [00601] Figure 85C shows a portion of the 8500 valve with parts removed for clarity. As shown in Figure 85C, plunger 8512 is connected to output shaft 8520 on actuator 8510 which drives plunger 8512 in and out of the first cup portion 8504. Springs 8516 are placed between the plunger stabilizing arms 8514 and the 8510 actuator to force the 8512 plunger away from the 8510 actuator. The 8516 springs help counteract the force placed on the plunger by filling 8621 (see Figure 86) allowing an 8510 actuator that exerts less peak force.

[00602] In some embodiments of the present description, the plunger head 8512a has a smaller area than the longitudinal cross section of the tube inside the valve housing 8502, 8504. The smaller head 8512a results in a smaller change in pressure when compared to a similar displacement with a larger head. In some embodiments, this may allow for more precise changes in tube deformation by the 8510 actuator.

[00603] The first shell portion 8504 and the second shell portion 8502 have semicircular cutouts on the sides adjacent to the hinged side to create the holes to create the 8518 holes (see Figure 85B). The cutouts are positioned to align when the liner is in the closed position, creating hole 8518. Hole 8518 allows a flexible tube (such as a PVC IV tube) to pass through the 8502, 8504 closed hard liner without being deformed.

[00604] Figure 86 shows a cross-sectional view of the valve housing with the substantially incompressible filling 8621 contained therein. The substantially incompressible filler 862 is contained in the first and second shell portions 8502, 8504. The first layer 8628 and the second layer 8626 are within the first shell portion 8504, while the third layer 8624 and the fourth layer 8622 are within the second portion of

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167/190 shell 8502. The second layer 8626 and the third layer 8624 are in the middle when the liner is closed and form a conduit 8618, within which the tube is placed, to assist in consistent deformation of the tube. Conduit 8618 connects holes 8618 defined by closed shell portions 8502, 8504.

[00605] The materials used to make some flexible tubes may be susceptible to wrinkling, which affects the tube's ability to return to its original shape after multiple deformations. The second layer 8626 and the third layer 8624 are more rigid than the first layer 8628 and the fourth layer 8622 in order to consistently reform the tube when the wrinkling begins to affect the shape of the tube. The stiffer second layer 8626 and the third layer 8624 are less affected by wrinkling than the tube and will reform back to their original shape after many deformations. Therefore, when filling 8621 is attempting to reform the original shape of the 8618 duct, it will reform the tube inside the duct.

[00606] Also, in some embodiments, the tube has a tendency to adhere to itself when deformed to a point where the inner surfaces of the tube contact each other. This makes it difficult to control very low drip rates when the tube is almost completely closed. The rigid layers surrounding the tube 8624, 8626 apply sufficient forces to overcome the adhesion forces, which in turn results in the tube opening evenly.

[00607] The first layer 8528 and the fourth layer 8522 fill the space between the second layer 8526 and the third layer 8524, and the shell portions 8502, 8504. The second layer 8526 and the third layer 8524 are more smooth in order to disperse the force of the plunger 8512 evenly across the entire section of the tube within the shell portions 8602, 8504. Instead of transferring the direct force

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168/190 to the area of the tube just above the plunger 8512, the plunger 8512 increases the pressure in the shell portions 8602, 8504. This causes a substantially uniform deformation of the contained section of the tube. A uniform deformation is advantageous because the frictional forces between the liquid and the tube help with the flow rate pressure of the valve. A longer deformed section prints more frictional force on the liquid as it flows through, slowing its flow rate. Extending the section of the tube being valved allows for a low flow rate with a larger, more controllable lumen diameter.

[00608] The soft layers 8622, 8628 preferably have a shore OO hardness of approximately 20 to approximately 25. The hard layers preferably have a shore A hardness of approximately 15. In some embodiments, preferred materials for filling include silicone, urethane, viton, or nitrile.

[00609] Figures 87A-87D show an 8700 flow control apparatus according to an embodiment of the present description. The 8700 flow control device includes an 8702 device liner which contains an 8732 valve and an 8734 safety cutout (see Figure 87B). As is easily seen in Figure 87B, cover 8702 includes a door 8702b and a body 8702a. A drip chamber case 8714 having a top component 8714a and a bottom component 8714b is attached to the body 8702a and is configured to orient the drip chamber vertically. A laser 8708 and a diffraction device 8716 are attached to the body 8702a of the coating 8702 and are aligned to diffract the laser light so that it creates a pattern on the charged drip chamber inside the 8714 drip chamber case. drip not shown in Figure 87). An 8710 image sensor, which has the drip chamber and the diffraction patterns in its field of view, is also attached to the device coating

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8702.

[00610] In some embodiments, the laser beam is first divided by a beam splitter into a first and second beam so that the first beam is directed to a higher diffraction device 8716a and the second beam is directed to a lower diffraction 8716b. The beam splitter can be part of the laser beam output lens.

[00611] The upper diffraction device 8716a directs its pattern to an upper section of the drip chamber and the lower diffraction device 8716b directs its pattern to a lower section of the drip chamber. Diffraction devices 8716a, 8716b can use, in some modalities, binary optical films to redirect and reshape the laser beams into patterns. The upper film of the upper diffraction device 8716a converts the beam into a network of points, or in some embodiments, a single point. This creates the contrast for the 8710 image sensor to track the growth of the drop that develops on top of the drip chamber. The lower film of the lower diffraction device 8716b converts the beam into a horizontal strip pattern. The strips create the contrast for the 8710 image sensor to determine if the fluid is flowing rather than dripping.

[00612] As is easily seen in Figure 87B, this modality has a valve closing arm 8720 connected to port 8702b of liner 8702 and inlet end 8722a of latch component 8722. When port 8702b is open, the arm closing cap 8720 pulls on the inlet end 8722a of the female latch component 8722 causing it to rotate upward and away from the 8732 valve. This releases the pressure placed on valve 8732 from the outlet end 8722b of the female latch component 8722. Once the latch component was

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170/190 mea 8722 uncouples the male latch component 8728, the closing arm 8720 pulls open the valve cover shells 8732a, 8732b by pulling the female latch component 8722 away from the 8732 valve. When port 8702b is fully open, the shells 8732a, 8732b are open far enough for an operator to remove or insert a tube being valved into the 8732 valve (the open position is shown in Figure 87B). Once a tube is placed inside the 8732 valve, an operator closes port 8702b. Closing the door 8702b causes the closing arm 8720 to engage the female latch component 8722 so that the outlet end 8722b of the female latch component 8722 coincides with the male latch component 8728 whereby an additional actuation rotates the 8722 female latch component to a clamped position (similar to the 8500 valve position shown in Figure 85B). The 8720 closing arm adds efficiency to the 8700 appliance adjustment process and improves safety by ensuring that the 8732 valve is securely closed when port 8702b is closed.

[00613] The operator deposits the tube through the safety cut 8734 (the physical mechanics of the safety cut is described in relation to Figure 69) together with the 8732 valve when adjusting the 8700 device (refer to Figure 87C). The 8734 safety cut uses spring-loaded occlusion arms 8739a, 8739b to compress the tube into an 8741 stop when fired. A solenoid applies the force to trigger the mechanism and release the occlusion arms 8739a, 8739b. Once the occlusion arms 8739a, 8739b are released, they substantially cut the luxury through the tube, and finally to the patient, compressing the tube against the 8741 stop. The 8734 security cut is triggered by a processor which uses a safety sensor to detect unplanned events.

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Unplanned events may include loss of energy, the 8700 device falling, fluid flowing through the drip chamber, or the flow rate not properly correlating with the position of the 8732 valve. The last of these examples can resolve a situation where the tube is bent somewhere between the device and the patient.

[00614] An 8735 safety shutoff reset arm can be attached to port 8702b and is configured to reset the 8734 safety shutoff valve to the free flow position by opening port 8702b of liner 8702. The safety shutoff valve 8734 used in this modality is similar to the valve described in Figure 69. However, in Figure 87, the occlusion arm 711 in Figure 69 is extended beyond the screw 714 of Figure 69 creating a flap that projects out from the bottom. The 8734 safety shut-off valve of Figure 87B includes this flap 8740 as shown in Figure 87C.

[00615] Referring to Figure 87C, the reset arm 8735 includes three members 8736, 8738, 8742. A first member 8736 of the reset arm 8735 is attached to port 8702b and a second member 8738 of the reset arm 8735. The second member 8738 of the reset arm 8735 is attached to a third member 8742 of the reset arm 8735. Opening the door 8702b acts the first member 8736, which in turn acts the second member 8738 and the third member 8742. The third member 8742 it has a projection configured to attach the 8740 flap and force it back to the parallel non-coupling position (as shown in Figure 69D) when it engages the 8740 flap. In additional modes, the reset of the 8734 security cut can be performed with fewer or more members if desired.

[00616] Figure 87D shows an embodiment of the present description

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172/190 tion designed to stop the flow of fluid through the valve tube when port 8702b is in an open position. A 8744 compression flap can be used to substantially cut the flow through the tube being valved when the device overlay door 8702b is open. When installing a tube, an operator inserts the tube into slot 8745 between the compression flap 8744 and the sheath 8702a. When the door is open, the full force of the compression tab 8744 is exerted on the tube, substantially cutting off the flow by deforming the tube. When port 8704b is closed, a wedge 8746 attached to port 8702b is forced into slot 8745 and forces compression tab 8744 open. Forcing the 8744 flap open allows the tube to reopen allowing fluid to flow. This feature is used as a safety mechanism to make sure that no liquid from the drip chamber is administered to the patient when an operator is adjusting the device.

[00617] Actuation of the 8732 valve causes minor pressure changes in the 8702 device liner. An 8748 hole network can be defined in the 8702a device liner body. These holes allow the pressure inside the jacket to equalize with the pressure outside the jacket 8702, which can increase accuracy in some modes.

[00618] Referring again to Figure 87A, in some embodiments of the present description, a 8718 status light can be used to visually display the status of the 8700 flow control device. The 8718 light is attached to the 8700 flow control device in a location that can be readily seen by a close person. In some embodiments, the 8718 status light will emit a first color when the fluid is flowing and a second color when the flow has stopped. In other modalities, the 8718 status light will emit a first

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173/190 color when the 8700 flow control device is operating properly, a second color when the 8700 flow control device has detected a problem, and a third color when the 8700 flow control device is paused. The 8718 status light can also be configured to flash each time a drop falls into the drip chamber. This feature allows an operator to see the drip rate from a distance where it would not be possible to read the 8704 display.

[00619] A certain modality of the present description can use a battery as a source of energy. Other modalities can use a combination of a battery and an AC wall adapter, or just an AC wall adapter.

[00620] In another embodiment of the present description, the 8700 apparatus includes 8706 input buttons and an 8704 display. The 8706 input buttons can be used to control the flow of liquid through the drip chamber. This allows an operator to adjust the flow rate initially and adjust the flow rate when desired. In other modes, the 8706 input buttons can be configured to adjust any adjustable parameters of the 8700 device. The 8706 input buttons can be lit in different colors to assist a user. For example, a green input button for 8706 input buttons can be used to increase or decrease the flow rate, a yellow button for 8706 input buttons can be used to pause the flow, and a red button for 8706 input buttons. can be used to stop the flow of fluid. The 8704 display can display infusion information that includes the current flow rate and the adjusted flow rate, to inform an operator. The 8704 display can also display information regarding the patient, the device, or the fluid being supplied by the device. For example, the status of the batteries, any alarms, or the sequence of

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174/190 patient identification.

[00621] A processor can also be communicating with a 8718 status light. The processor can tell the 8718 status light to emit a first color when the fluid is flowing and a second color when the flow has stopped. The 8718 status light can also emit a first color light when the pump is operational and a second color light when a problem has been detected. e The first color is likely to be green and the second color is likely to be red.

[00622] Certain modalities can use an audio output device to communicate with an operator. For example, this device can signal an error, update an operator on the status of the pump, or guide an operator through a configuration of the 8700 flow control device.

[00623] Referring now to Figures 88A-88E: Figure 88A shows a perspective view of a fluid flow apparatus 8800 used to control fluid flow through an 8820 drip chamber connected to an 8821 tube, in which the apparatus 8800 has dressing door 8809b open; Figure 88B shows a perspective view of only the valve 8801 of Figure 88A; Figure 88C shows internal parts of valve 8801 of Figure 88B; Figure 88D shows a simplified diagram illustrating the operation of the valve shut-off mechanism in a closed 8809b port position; and Figure 88E shows a simplified diagram to illustrate the valve shut-off mechanism in the open port position 8809b according to an embodiment of the present description.

[00624] Flow control device 8800 prevents flow through a tube 8821 into valve 8801 when the cover port 8809b is open. The coating door 8809b is hingedly coupled to the coating body 8809a. In this modality, the

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175/190 actuator 8802 and plunger 8816 attached (see Figure 88c) are connected to valve 8801 by springs of 8806 (see Figure 88B) that force plunger 8816 into the filling disposed inside valve housing 8801. Plunger 8816 is secured on the 8802 actuator by a threaded drive shaft 8812, and in some embodiments it is able to freely rotate on the drive shaft 8812. This allows the plunger 8816 to maintain a constant orientation while the drive shaft 8812 rotates. A half nut 8811 on the end of the coupling member 8810 is operatively connected to the fluid flow apparatus 8800 so that the half nut 8811 has the ability to couple and uncouple the threaded drive shaft 8812 with the threads of the half threaded nut 8811.

[00625] When the appliance casing door 8809b (see Figure 88A) is closed, the half nut 8811 (see Figure 88C) is coupled with the drive shaft 8812 to allow the 8802 actuator to control the position of the plunger 8816 by turning the threaded drive shaft 8812. Opening the device casing door 8809b (see Figure 88A) disengages the half nut 8811 (see Figures 88B-88C) from the drive shaft 8812 (the half nut 8811 moving away from the drive shaft), leaving only the cutting springs 8806 to control the position of the plunger 8816. The cutting springs 8806 drive the plunger 8816 into the filling with sufficient force to substantially cut off the flow of fluid through the 9921 tube coupled to the 8820 drip chamber (also see Figure 88A). This mechanism can serve the same purpose as the compression flap described in Figure 87.

[00626] Figures 88D-88E illustrate the mechanism that couples and uncouples the half nut 8811 with the threaded drive shaft 8812. An 8810 coupling member has a half nut 8811 on one end and hinged to a pivot member

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176/190 tion 8803 at the other end. The hinge member 8803 is anchored by a hinge 8818 (coupled to the sheath 8809a) and is positioned to be coupled by a tensioning component 8805 connected to the sheath door 8809b. The tensioning component 8805 is coupled to port 8809b (shown in Figure 88A).

[00627] Figure 88D shows the position of the mechanism when the coating door 8809b is closed. In this position, the tensioning component 8805 is not coupled with the hinge member 8803, leaving only the spring force 8814 to influence the position of the connected hinge members 8803 and coupling 8810. Spring 8814 tensions pivot member 8803 to rotate counterclockwise, as seen in Figure 88D. The rotational force translates to a force that pushes coupling member 8810 into threaded drive shaft 8812 due to link 8818.

[00628] Figure 88E shows the position of the mechanism when the coating door 8809b is open. Opening the door 8809b causes the tensioning component 8805 to rotate and engage the hinge member 8803. This counteracts the force of the spring 8814 and rotates the hinge member 8803 clockwise, with respect to the view in Figure 88E. The hourly rotation of the hinge member 8810 decouples the coupling member 8803 from the threaded drive shaft 8812.

[00629] Figure 89 shows a method for controlling the flow of fluid through the drip chamber according to an embodiment of the present description. The method includes an 8902 installation act. During the 8902 installation act, a flexible pipe in fluid communication with a drip chamber is substantially deformed while being installed in a flow control device.

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177/190 fluid flow by an operator. In the reformatting act 8904, the tube is reformed to substantially its initial size once the installation process is complete. In the act of forming image 8906, images are captured from the drip chamber in fluid communication with the tube. In the act of estimating 8908, the images from the previous act are used to estimate the flow rate through the drip chamber. In the act of communicating 8910, the estimated flow rate is communicated to a fluid monitoring client. Upon receiving 8912, a desired flow rate is received from a user. The user can be a fluid monitoring client or a device operator. In comparing 8914, the estimated flow rate is compared with the desired flow rate and a difference produced. In determining 8916, the magnitude and direction of actuation of the valve to achieve the desired flow rate are determined using the difference from the previous act.

[00630] Referring now to Figure 89B, in the act of acting 8918, the valve is actuated according to the magnitude and direction determined to achieve the desired flow rate. Valve actuation can be achieved by increasing the pressure around a defined section of the tube which deforms the tube and changes the shape of the lumen within the tube. A pressure adjustment can be achieved by arranging a rigid housing around a defined section of the tube and by coupling a plunger with a substantially incompressible filling material contained within the housing. The filling material moves the plunger into coupling to press into the housing thereby deforming the tube.

[00631] In the act of illuminating 8920, a light is emitted to indicate the status of the device that performs this method. A first color of light can be emitted to indicate that the fluid is flowing and a second light can be emitted to indicate that the flow has stopped. A first color

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178/190 of light can be used to indicate that the device is working properly and a second light can be used to indicate that a problem has been detected.

[00632] In the act of monitoring 8922, the method monitors unplanned events. Unplanned events can be loss of energy or a device that performs this method falling. In the act of cutting 8924, the flow of fluid through the drip chamber is stopped when an unplanned event is detected by the act of monitoring. In the act of removing 8926, the tube is deformed to substantially reduce its lumen size while it is being removed from an apparatus that performs this method.

[00633] As shown in Figure 90, a 9000 system is shown. The 9000 system can be used with the flow control device 8700 of Figures 81A-87D or the flow control device 8800 of Figures 87A-87D. The 9000 system includes a 9002 processor in communication with the 9006 image sensor and the 9004 valve actuator. The 9002 processor receives the image data from the 9006 image sensor. Once the 9002 processor received the image data from the image 9006, the processor uses the data to estimate a flow rate. The 9002 processor then compares the estimated flow rate with a desired flow rate, and produces a different one between the two values. The 9002 processor adjusts the valve actuator 9004 based on the value to achieve the desired flow rate.

[00634] Processor 9002 can also be in communication with a safety sensor 9008 and safety cut 9010. In this mode, the 9002 processor receives data from the safety sensor 9008 and determines when the fluid flow should be stopped based on criteria predetermined (such as loss of power, flow, or device malfunction). Since the processor

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179/190 ends that the fluid flow must be stopped, this triggers the safety cut 9010.

[00635] Processor 9002 may also be in communication with input buttons 9012. Processor 9002 receives data from input buttons 9012 and uses this data to control valve actuator 9004 or trigger safety cut 9010. For example, when the operator presses the flow increase button 9012 the processor 9002 receives a signal from the button 9012 and adjusts the valve actuator 9004 accordingly, or when the operator presses the stop button 9012 the processor 9002 receives a signal and directs the safety cut 9010 to fire. The 9002 processor can also send data to the 9012 input buttons, as well as data on what color the button should light.

[00636] The 9002 processor may also be in communication with the 9014 display. The 9002 processor receives data from the various device components such as the 9004 valve actuator, the 9008 safety sensor, the 9006 image sensor, or the input 9012 and then outputs the data in human-readable form on the 9014 display. For example, the 9002 processor receives data from the 9006 image sensor, estimates a flow rate, and displays the estimated flow rate on the 9014 display.

[00637] Processor 9002 can also be in communication with status light 9018. Processor 9002 receives data from the various components of the device such as valve actuator 9004, safety sensor 9008, image sensor 9006, or the input buttons 9012, creates a signal to send to the 9018 status light based on the data and outputs the signal to the 9018 status light. Examples include, flashing the 9018 light every time a drop falls into the drip chamber, turn on the 9018 green light when the pump is operational, turn on the yellow 9018 light when the pump is paused, or read

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180/190 the red 9018 light when the pump is not operating correctly.

[00638] The 9002 processor can also be in communication with a power supply or 9016 battery. The 9002 processor receives data from the power supply or 9016 battery for the power output. For example, taking battery voltage 9016 to estimate how much charge it has. The 9002 processor can also send data to the 9016 power supply to adjust its power output.

[00639] Figure 91 shows an apparatus 9100 configured to control the flow of fluid through a drip chamber connected with a tube and to communicate an RFID interrogator according to an embodiment of the present description. The 9100 apparatus can transmit data to and from a commercially available radio frequency identification (RFID) interrogator without the use of a dedicated RFID tag.

[00640] As shown in Figure 91, a first metallic structure 9102 is coupled to a second metallic structure 9104. Preferably, the first metallic structure 9102 and the second metallic structure 9104 are pre-existing components of the assembly. For example, the first metal structure 9102 could be a first shell 9106 and the second metal structure 9104 could be a second shell. Alternatively, the first metallic structure 9102 could be a first metallic geometry 9110, such as a metallic housing of a solenoid, and the second metallic structure 9104 could be a second metallic geometry 9112, such as a ground plane of a PCB circuit board. . Although it is preferable that the first metallic structure 9102 and the second metallic structure 9104 are pre-existing components of the set, in some specific embodiments, these structures could be additional to the set

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181/190 for this use only.

[00641] At least one impedance matching structure 9116, such as an inductor or capacitor, can be coupled with the first metal structure 9102 and the second metal structure 9104 to match the impedance of the device with the interrogator frequency. In some embodiments, more than one 9116 impedance matching structure can be used in combination, such as a combination of an inductor and a capacitor (for example, in a parallel or series configuration, to form a tank circuit).

[00642] At least for the purpose of earth continuity, a low-pass filter 9114 is preferably coupled with the first metal frame 9102 and the second metal structure 9104. The low-pass filter 9114 preferably has a sufficient cutoff frequency below the frequency (approximately 900 MHz) of a commercially available RFID 9122 interrogator.

[00643] The 9100 device operates by performing at least two functions. In a first function, apparatus 9100 is matched by impedance at the interrogator frequency used to at least one impedance matching structure 9116, limiting or essentially prohibiting reflection of the interrogator frequency. In a second function, the metal structures 9102, 9104 are shorted together using a 9118 shorting mechanism, such as a transistor or switch. The short can be controlled by a 9120 microprocessor. This short momentarily eliminates the impedance match and causes a change in reflection. The transition from the first function to the second function causes a shift in the reflection coefficient of the first metallic structure 9102 and second metallic structure 9104 coupled. Shorting the metal structures 9102, 9104 together as desired, data can be transmitted

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182/190 for a commercially available RFID 9122 interrogator, encoded in the resulting gamma reflection.

[00644] In some embodiments, an obstruction (for example, condensation or droplets due to splashing) can make obtaining an accurate image of a drip chamber by an image sensor (for example, drip chamber 4 and the image sensor 11 in Figure 1) difficult. Figure 92 is an image of such an obstructed drip chamber 9200. The drip chamber 9202 includes a drop of fluid 9204 and an obstruction 9206. The obstruction 9206 may include condensation fluid droplets or splashes in some embodiments. Fig. 93 shows a flow chart of a 9300 method for obtaining an image of a drip chamber according to an embodiment of the present description. Method 9300 includes acts 9302, 9304, 9306, and 9308. Method 9300 can be implemented by processor 15 in Figure 1 and can be implemented with a method implemented by processor, such as a set of instructions configured for execution by one or more processors, hardware, software, the like, or some combination thereof.

[00645] Act 9302 of method 9300 includes capturing an image from a drip chamber. Act 9304 of method 9300 includes determining that the image of the drip chamber includes a visual obstruction. The visual obstruction may be similar to the visual obstruction shown in Figure 92 in some modalities. Act 9306 of method 9300 includes applying a blur function to the captured image of act 9302 when it is determined that the captured image of act 9302 contains a visual obstruction. The turbidity function can be any function that decreases the amount or eliminates an amount of detail in the captured image of act 9302. In some embodiments, the turbidity function can be applied without regard to a determination that the captured image of act 9302 contains

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183/190 has a visual obstruction, that is, the turbidity function is always applied to the captured image of act 9302.

[00646] In some embodiments, the turbidity function of act 9306 may include applying a low-pass filter to the captured image of act 9302. The low-pass filter or other turbidity function can be applied either in a horizontal direction (for example , an X direction in Cartesian coordinates) of the captured image from act 9302, or a vertical direction (for example, a Y direction in Cartesian coordinates) from the captured image from act 9302. In some embodiments, the low-pass filter or turbidity function it can be applied in both horizontal and vertical directions (for example, in both X and Y directions in Cartesian coordinates) of the image captured from act 9302.

[00647] In some embodiments, the turbidity function of act 9306 may include applying a Gaussian Turbidity function to the captured image of act 9302. If the turbidity function or the low-pass filter is applied either in a vertical or horizontal direction, as described above, the low-pass filter or turbidity function can then include a one-dimensional Gaussian Turbidity function in some embodiments. If the turbidity function or the low-pass filter is applied in both a vertical and horizontal direction, as described above, the low-pass filter or turbidity function can then include a two-dimensional Gaussian Turbidity function in some modalities.

[00648] After the turbidity function is applied, sufficient details must be eliminated from the captured image so that act 9308 can be performed. Act 9308 includes determining whether the captured image from Act 9302 contains a match with a template. In some embodiments, a processor (for example, processor 15 in Figure 1) may use a template matching function

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184/190 to determine whether the image captured from act 9302 contains a match with the template. In some embodiments, the template matching function can be an OpenCV template matching function. The template can include at least a partial image of a drop of fluid. In some embodiments, the template may include at least a partial image of the fluid drop being illuminated from behind by a light source. In yet an additional embodiment, the light source may include a network of LEDs (for example, the network of LEDs 20 in Figure 1).

[00649] Figure 94 is a 9400 graphical representation of a modality that presents a plurality of drops successively growing inside a drip chamber until each one falls, as seen by an image sensor (for example, drip chamber 4 and the image sensor 11 of Figure 1). The image sensor communicates an output signal to a processor (for example, processor 15 in Figure 1), the processor configured to determine the output signal when a drop of fluid has fallen into the drip chamber. Curve 9408 to the left of time marker 9406 represents the output signal from the image sensor before applying a turbidity function (for example, the turbidity function of act 9206 in Figure 92). Similarly, curve 9410 to the right of time marker 9406 represents the output signal from the image sensor after applying the turbidity function. According to curve 9408 and curve 9410 of Figure 94, the application of the turbidity function can reduce the amount of noise in the image sensor's output signal. This noise reduction in the output signal allows the processor to more efficiently identify, from the image sensor's output signal, when a drop of fluid has fallen into the drip chamber.

[00650] In some modes, the processor is configured

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185/190 to recognize that a drop has fallen into the drip chamber, but only if certain current events and previous events have occurred, that is, the processor performs a hysteresis function. In one embodiment, the processor will recognize that a drop has fallen into the drip chamber when the curve crosses a lower threshold limit 9404, but only if the curve previously crossed an upper threshold limit 9402 since the previous crossing of the lower threshold limit 9404 This hysteresis function can be used to prevent the processor from mistakenly recording that a drop has fallen due to noise in the image sensor's output signal.

[00651] Referring now to Figure 95, in some embodiments, it may be desirable to rely on some other means than or in addition to an audible noise or visual indicator to drive the status of a 9500 device. This may be desirable where a 9500 device is used in an environment with high levels of ambient noise and or high level of ambient light respectively. This can, in some embodiments, be economically performed using a 9502 signature analyzer.

[00652] During the normal function of the 9500 device, EM emissions will be created. These broadcasts are a natural artifact of how digital functions are performed by the 9500 device. In addition, digital functions specific to the 9500 device will produce EM signatures in a predictive mode. That is, when a digital function is performed by the 9500 device, an EM emission that corresponds to that function can occur. In Figure 95, the 9500 device includes a 9504 component that can perform a digital function. This component can, for example, be a microprocessor, clock, etc.

[00653] EM signatures of specific functions can be empirically determined. A 9502 signature analyzer can monitor the EM emissions from the 9500 device. An EM signature

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186/190 received can be matched with its empirically determined meaning. In this way a 9502 signature analyzer can guess which digital functions are being performed by the 9500 device using the EM emissions from the 9500 device.

[00654] In a specific example, the 9500 device can be a drug delivery device. A drug delivery device can generate an occlusion alarm during the operation. The generation of this occlusion alarm will cause a specific EM signature to be issued from the medication delivery device. A 9502 signature analyzer that monitors the emissions from the medication delivery device can receive and analyze this specific emission signature and thereby determine that the medication delivery device is emitting an occlusion alarm.

[00655] Various components which create EM emissions can be contained within an EM 9506 shield. This 9506 shield can suppress emissions from the 9500 device so that the 9500 device does not interfere with other devices (not shown) in the vicinity and comply with any local requirements. The 9506 shield, however, will not entirely eliminate emissions from the 9500 device. Low-amplitude frequency emissions 9508 which satisfy regulatory compliance levels will still occur. In a modality which uses a 9502 signature analyzer to monitor the EM signature of a 9500 device, the 9502 signature analyzer can be properly positioned outside the 9506 shield and can monitor these reduced amplitude frequency emissions 9508. In such modalities , the 9502 signature analyzer can be an RF receiver such as a narrowband receiver. Such a receiver is capable of being tuned to very specific and low broadcast frequencies. In addition

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187/190 so, using a narrowband receiver may be desirable because such a receiver is relatively economical.

[00656] In some embodiments, a medical pump device can monitor the number of infusion sets that the medical pump device delivers. The medical pump device can track infusion sets using a software radio, operably connected to the medical pump device. The software radio may include a coiled wire operatively coupled with a microchip in the medical pump device, so that the microchip can transmit signals through the coiled wire. The software radio, in some modalities, can be used to transmit a communication signal to a device that is configured to receive the. The communication signal can be a number of infusion sets that the medical pump device administered.

[00657] Also, in some embodiments, the medical pump device can communicate with the portable device through a speaker on the portable device configured to receive an acoustic or audio signal from the medical pump device. The audio signal, in some embodiments, may include digital data that is encoded in the audio signal.

[00658] In some embodiments, the medical pump device communicates with a portable device using a motion sensor on the portable device. The motion sensor can receive a motion input from a motion generator included in the medical pump device. The motion generator, in some modalities, can be a stepper motor, and, in some modalities, the motion sensor can be an accelerometer. The handheld device may be configured to determine a number of infusion sets that the medical pump device has administered

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188/190 of the inserted motion received by the motion sensor.

[00659] The medical pump device may be configured to pair with a portable device in order to establish wireless communication with the portable device. In some embodiments, the medical pump device can establish a Bluetooth connection with the portable device. In still other embodiments, the medical pump device can establish a wireless communication signal with the handheld device using near field communication (NFC) signals.

[00660] In some embodiments, the medical pump device can communicate with a portable device using a camera that is included in the portable device. More specifically, the handheld device's camera may be configured to detect a visual modulation signal. In some embodiments, the visual modulation signal can come from a dome light included in the medical pump device. The portable device can use the visual modulation signal to determine a number of infusion sets that have been administered by the medical pump device.

[00661] Various alternatives and modifications can be foreseen by those skilled in the art without departing from the description. Consequently, the present description is intended to cover all such alternatives, modifications and variances. In addition, although several modalities of the present description have been shown in the drawings and / or discussed here, the description is not intended to be limited to these, and it is intended that the description be as broad in scope as the technique will allow and that specification is read in the same way. Therefore, the above description should not be considered as limiting, but merely as exemplifications of specific modalities. And those skilled in the art will imagine other changes within the scope and spirit of the claims attached to it. Other elements,

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189/190 steps, methods and techniques that are insubstantially different from those described above and / or in the appended claims are also intended to be within the scope of the description.

[00662] The modalities shown in the drawings are presented only to demonstrate certain examples of the description. And, the drawings described are only illustrative and not limiting. In drawings for illustrative purposes, the size of some of the elements may be exaggerated and not drawn on a specific scale. In addition, elements shown in the drawings that have the same numbers can be identical elements or they can be similar elements. depending on the context.

[00663] Where the term comprising is used in the present description and claims, it does not exclude other elements or steps. Where an indefinite or defined article is used when referring to a singular noun, for example, one, one, or o, it includes a plural of that noun unless something else is specifically stated. Thus, the term comprising should not be interpreted as being restricted to the items listed later; it does not exclude other elements or steps, and so the scope of the expression a device comprising items A and B should not be limited to devices consisting only of components A and B. This expression means that, with respect to this description, only relevant components of the device are A and B.

[00664] Furthermore, the terms first, second, third, and the like, if used in the description or in the claims, are provided to distinguish between similar elements and not necessarily to describe a sequential or chronological order. It should be understood that the terms thus used are interchangeable under appropriate circumstances (unless clearly described otherwise)

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190/190 and that the description modalities described herein are capable of operation in other sequences and / or dispositions than are described or illustrated herein.

Claims (12)

1. System, characterized by comprising: a coupler adapted to couple with a drip chamber; a support member operatively coupled to the coupler; an image sensor that has a field of view and operatively coupled to the support member, in which the image sensor is positioned to see the drip chamber within the field of view; a valve fluidly coupled to the drip chamber to regulate the flow of fluid through the drip chamber, the valve comprising: a housing configured to surround a tube fluidly coupled to the drip chamber, the housing defining a hole; a filling disposed within the housing, the filling having at least two layers of different stiffness; a plunger configured to couple the filler inside the housing through the hole to thereby operationally deform the tube inside the housing when coupling the filler; and an actuator operatively coupled to the plunger and configured to actuate the plunger; and at least one processor operatively coupled to the image sensor and actuator to operatively control the valve, where: o at least one processor receives image data from the image sensor, o at least one processor estimates at least one liquid parameter inside the drip chamber using those of Petition 870170016724, of 3/14/2017, p. 198/347 2/3 of the image, and at least one processor acts on the plunger to reach a target parameter. 2. System according to claim 1, characterized by the fact that the at least one parameter is one of a type of liquid formation, a volume of the liquid, and a shape of the liquid. System according to claim 1, characterized by the fact that the at least one processor determines the existence of a flow condition using the image data. System according to claim 1, characterized in that it also comprises a background pattern positioned within the field of view of the image sensor, in which the drip chamber is between the image sensor and the background pattern. 5. System according to claim 1, characterized by the fact that the target parameter is a target flow rate. 6. System according to claim 1, characterized by the fact that the target parameter is a target drop growth rate. 7. System according to claim 1, characterized by the fact that the valve housing includes a first and a second shell portion. 8. System according to claim 7, characterized by the fact that the valve still comprises a guide coupled to the actuator and to a first shell portion, in which the guide is configured to guide the plunger through the hole in the first shell portion . 9. System according to claim 1, characterized by the fact that the housing includes a first and a second shell portion, Petition 870170016724, of 03/14/2017, p. 199/347 3/3 the first shell portion is hingedly coupled to the second shell portion, the first and second shell portions have an open position and a closed position, and the first shell portion defines a first portion of the cavity and the second portion of shell defines a second portion of the cavity so that the first and second shells form a cavity when in the closed position. System according to claim 9, characterized in that the at least two layers of different hardness of the filler include a first, second, third, and fourth layer, and the first and second layers are within the first portion of the cavity and the third and fourth layers are within the second portion of the cavity. System according to claim 10, characterized in that the first layer is arranged on an internal surface of the first shell portion that defines the first portion of the cavity and the second layer is arranged on the first layer. 12. System according to claim 11, characterized in that the second layer defines a channel to guide the tube.